11.5MM MONOBLOC FLEXIBLE REAMER - STANDARD
Report
- Report Number
- 2939274-2022-00214
- Event Type
- Malfunction
- Date Received
- January 19, 2022
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HTO
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNK - REAMERS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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.
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. H6: PART: 03.045.115; SYNTHES LOT: N169923; SUPPLIER LOT: N169923; RELEASE TO WAREHOUSE DATE: JANUARY 05, 2021; SUPPLIER: (B)(4). NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. 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. PHOTO INVESTIGATION THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE RECEIVED IMAGE. UPON INSPECTION, THE SHAFT OF THE REAMER WAS BROKEN. NO OTHER ISSUES WERE IDENTIFIED FROM THE PROVIDED IMAGES. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION WAS NOT PERFORMED. DOCUMENT/SPECIFICATION REVIEW: DOCUMENT REVIEW COULD NOT BE PERFORMED AS THE EXACT PRODUCT CODE COULD NOT BE DETERMINED FROM THE IMAGES PROVIDED. CONCLUSION: THE COMPLAINT CONDITION COULD 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.
IT WAS REPORTED THAT, DURING A PROCEDURE ONE OF THE MONOBLOC REAMER WAS FAILED. THIS REPORT IS FOR ONE (1) UNK - REAMERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 804639 | 11.5MM MONOBLOC FLEXIBLE REAMER - STANDARD | REAMER | HTO | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | N169923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |