REMOVABLE EXT ARM-RIGID 20 FOR CMF DISTR
Report
- Report Number
- 2939274-2021-05414
- Event Type
- Malfunction
- Date Received
- September 14, 2021
- Report Date
- August 17, 2021
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- MQN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D2B: ADDITIONA DEVICE PRODUCT CODES: PBJ. THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE X-RAYS AND ON IMAGES. UPON INSPECTING ALL THE IMAGES AND X-RAYS PROVIDED UNDER NOTES & ATTACHMENTS SECTION, IT IS OBSERVED THAT THE END CAP AND THE MACHINE SCREW ARE SEPARATED FROM THE AB DISTR BODY END ACT. U-JNT 15 CMF DSTR, HENCE THE ALLEGATION CONFIRMED. THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A MRE REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION BECOME AVAILABLE, THE RECORD WILL BE RE-ASSESSED AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION THE COMPLAINT CONDITION CAN BE CONFIRMED DURING PHOTO/VIDEO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: UPDATED DATA: B5, B7, D9, E1. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D1. BRAND NAME. D3. MANUFACTURER NAME AND ADDRESS. D4. UNIQUE IDENTIFIER( UDI), LOT, CATALOG, EXPIRATION DATE. D9. DATE DEVICE RETURNED TO MANUFACTURER. G1. MANUFACTURING SITE NAME AND ADDRESS. H4. DEVICE MANUFACTURE DATE. H6 - CODES UPDATED TO IMDRF CODES. VISUAL INSPECTION: THE REMOVABLE EXT ARM-RIGID 20 FOR CMF DISTR (P/N: 04.315.104 & LOT #: U149293) WAS RETURNED AND RECEIVED AT US CQ. THE REMOVABLE EXT ARM-RIGID 20 FOR CMF DISTR WAS RECEIVED ATTACHED TO THE AB DISTRACTOR BODY (PRODUCT CODE: 04.315.053, LOT NUMBER: 65P7038). UPON VISUAL INSPECTION NO ISSUES WERE IDENTIFIED WITH THE DISTRACTOR. HOWEVER THE DISTRACTOR WAS NOT CONNECTED TO THE END CAP AND THE MACHINE SCREW. FUNCTIONAL TEST: THE COMPLETE FUNCTIONALITY TEST CANNOT BE PERFORMED AS THE COMPONENTS OF THE DISTRACTOR (BONE SCREW, MACHINE SCREW, DISTRACTOR COLLAR, UNIVERSAL JOINT, EXTENSION ARM AND SILICONE TUBE OF FLEXIBLE EXTENSION ARM) WERE RECEIVED IN THE DISASSEMBLE POSITION. THE COMPONENTS COULD HAVE LOOSE DUE TO THE DEVIATION FROM THE FACTORS DESCRIBED UNDER THE PLANNING FOR THE APPROPRIATE TECHNIQUE REQUIRED AS PER THE CRANIOMAXILLOFACIAL (CMF) DISTRACTION SYSTEM SURGICAL TECHNIQUE DSUS/CMF/1114/0248(2) 12/19. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? UNABLE TO PERFORM DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT'S NOT PERTAINING TO COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED 04_315_104 REV E/REV C (CURRENT & MANUFACTURED) CRANIOMAXILLOFACIAL (CMF) DISTRACTION SYSTEM SURGICAL TECHNIQUE DSUS/CMF/1114/0248(2) 12/19. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS CONFIRMED FOR THE REMOVABLE EXT ARM-RIGID 20 FOR CMF DISTR (P/N: 04.315.104 & LOT #: U149293). NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED, HOWEVER THE DEVIATION FROM THE FACTORS TO CONSIDER BEFORE THE USE OF THE DISTRACTOR SYSTEM COULD HAVE CAUSE THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED.,BACKGROUND: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, ONE OF THE 3 DEVICES FAILED DURING THE CONSOLIDATION PHASE. THE END CAP AND MACHINE SCREW ARE SEPARATED FROM THE DISTRACTOR. THIS COMPLAINT INVOLVES ONE (1) DEVICE. PHOTO INVESTIGATION THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE X-RAYS IN "PC-000965151 ADDITIONAL INFORMATION FROM J&J EMPLOYEE WITH X-RAY PHOTOS 17AUG2021" AND ON IMAGES IN "PC-000965151 INTAKE EMAIL FROM J&J EMPLOYEE WITH DEVICE PHOTO 17AUG2021" LOCATED IN PC UNDER NOTES & ATTACHMENTS SECTION. UPON INSPECTING ALL THE IMAGES AND X-RAYS PROVIDED UNDER NOTES & ATTACHMENTS SECTION, IT IS OBSERVED THAT THE END CAP AND THE MACHINE SCREW ARE SEPARATED FROM THE AB DISTR BODY END ACT. U-JNT 15 CMF DSTR, HENCE THE ALLEGATION CONFIRMED. THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A MRE REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION BECOME AVAILABLE, THE RECORD WILL BE RE-ASSESSED AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION THE COMPLAINT CONDITION CAN BE CONFIRMED DURING PHOTO/VIDEO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY LOT :PART #: 04.315.104 SYNTHES LOT #: U149293 SUPPLIER LOT #: U149293 RELEASED TO WAREHOUSE: 27FEB2012 SUPPLIER: ORCHID UNIQUE NO NCRS WERE GENERATED DURING PRODUCTION.,NULL DEVICE HISTORY BATCH ==> NULL,NULL DEVICE HISTORY REVIEW ==> REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.,THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION BECOME AVAILABLE, THE RECORD WILL BE RE-ASSESSED.
UPDATED EVENT DESCRIPTION: THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED WITH BETTER MANDIBLE PROJECTION BUT WITH RIGHT DEVIATION OF THE MIDLINE.
PRODUCT COMPLAINT #: (B)(4). 510K: THIS REPORT IS FOR AN UNK - DISTRACTOR IMPLANTS: CRANIOMAXILLOFACIAL /UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE PROCEDURE, ONE OF THE 3 DEVICES FAILED DURING THE CONSOLIDATION PHASE. THE END CAP AND MACHINE SCREW ARE SEPARATED FROM THE DISTRACTOR. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK - DISTRACTOR IMPLANTS: CRANIOMAXILLOFACIAL. THIS REPORT IS 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1365951 | REMOVABLE EXT ARM-RIGID 20 FOR CMF DISTR | MANDIBLE DISTRACTION DEVICES | MQN | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | U149293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |