2.7MM/3.5MM TI VA-LCP POSTLAT DHP/9H/LT/153MM-XLNG-STER
Report
- Report Number
- 3006126083-2017-10009
- Event Type
- Injury
- Date Received
- March 1, 2017
- Report Date
- January 31, 2017
- Manufacturer
- SYNTHES RARON
- Product Code
- HRS
- PMA / PMN Number
- K120717
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODE: HWC. (B)(4). CONCOMITANT DEVICES REPORTED: THERAPY DATES: (B)(6) 2016; 1X PART 04.117.504S (VA-LCP DHP 2.7/3.5 MED LE LONG 4HO L108), 1X PART 04.211.014S LOT (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA), 1X PART 04.211.014S LOT (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA), 2X PART 04.211.016S LOT 9882518 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA), 1X PART 04.211.016S LOT 9851385 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA), 1X PART 04.211.016S LOT 9328268 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA), 1X PART 04.211.016S LOT 9834436 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA), 1X PART 04.211.018S LOT 9740066 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA), 1X PART 04.211.018S LOT 9877824 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA), 1X PART 412.107S LOT 8588751 (LOCKSCR Ø3.5 SELF-TAP L22 TAN), 1X PART 412.108S LOT 8293590 (LOCKSCR Ø3.5 SELF-TAP L24 TAN), 1X PART 412.108S LOT 9440360 (LOCKSCR Ø3.5 SELF-TAP L24 TAN), 2X PART 412.109S LOT 9249396 (LOCKSCR Ø3.5 SELF-TAP L26 TAN), 2X PART 412.109S LOT 9706620 (LOCKSCR Ø3.5 SELF-TAP L26 TAN), 1X PART 412.109S LOT 9743802 (LOCKSCR Ø3.5 SELF-TAP L26 TAN). (B)(6). THE PLATE BROKE POST-OP AND WILL REQUIRE A REVISION TO REMOVE AND REPLACE THE DEVICE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART # 04.117.309S / LOT # 9329222; MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 03.FEB.2015, EXPIRY DATE: 01.JAN.2025. NO NCRS WAS GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
MANUFACTURING EVALUATION AND PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED. PLATE WAS RECEIVED IN TWO PIECES. SURFACE SHOWS MARKS AND SCRATCHES. THE PLATE (VA-LCP DIST HUMERUSPL 2.7/3.5 DORSO-LAT / ARTICLE # 04.117.309S / LOT # 9329222) WAS PRODUCE AS IT SHOULD. NO ABNORMALITY IN PROCESS WAS FOUND. BASED ON THIS, THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. ROOT CAUSE FOR THIS BREAKAGE COULD NOT BE DETERMINED. AS IT WAS REPORTED THAT (SIX MONTHS AFTER THE SURGERY, IT WAS FOUND THAT THE VA LCP PLATE WAS BROKEN) WE ASSUME THAT AN OVERLOADING SITUATION COULD HAVE LED TO THIS BREAKAGE. ONE UNKNOWN SCREW WAS RETURNED BROKEN. ONLY SCREW HEAD RETURNED WITHOUT SHAFT. HEAD THREAD IS WORN. NO INVESTIGATION COULD BE PROVIDED ON THIS ARTICLE AS ARTICLE AND LOT NUMBER ARE UNKNOWN. IN ADDITION SHAFT SECTION IS MISSING AND MEASUREMENTS COULD NOT BE TAKEN AS HEAD THREAD IS WORN TOO. 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.
DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICES WERE USED IN SURGERY FOR HUMERAL DIAPHYSIS FRACTURE AND DISTAL HUMERAL FRACTURE ON (B)(6) 2016. THE SURGEON FIXED WITH BOTH VA LCP (VARIABLE ANGLE LOCKING COMPRESSION PLATE) PLATES AND INSIDE LONG 4 HOLE PLATE. SIX MONTHS AFTER THE SURGERY, IT WAS FOUND THAT THE VA LCP PLATE WAS BROKEN. THE SURGEON COMMENTED THE PATIENT HASN¿T FALLEN DOWN. HE ALSO COMMENTED THAT BECAUSE HE HAD TO INSERT THE PLATE NEAR THE DIAPHYSIS, HE FIXED IT AS BENDING WHEN THE PLATE WAS IMPLANTED. REVISION SURGERY IS PLANNED ON (B)(6) 2017. AN UNKNOWN SCREW WAS FOUND DURING INCOMING INSPECTION, IT IS UNKNOWN WHEN THIS SCREW BROKE. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME. THIS COMPLAINT INVOLVES 2 PARTS. CONCOMITANT DEVICE: 1X PART 04.117.504S, LOT 9303677 (VA-LCP DHP 2.7/3.5 MED LE LONG 4HO L108); 1X PART 04.211.014S, LOT 9869931 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA); 1X PART 04.211.014S, LOT 9785988 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA); 2X PART 04.211.016S, LOT 9882518 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.016S, LOT 9851385 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.016S, LOT 9328268 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.016S, LOT 9834436 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA); 1X PART 04.211.018S, LOT 9740066 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA); 1X PART 04.211.018S, LOT 9877824 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA); 1X PART 412.107S, LOT 8588751 (LOCKSCR Ø3.5 SELF-TAP L22 TAN); 1X PART 412.108S, LOT 8293590 (LOCKSCR Ø3.5 SELF-TAP L24 TAN); 1X PART 412.108S, LOT 9440360 (LOCKSCR Ø3.5 SELF-TAP L24 TAN); 2X PART 412.109S, LOT 9249396 (LOCKSCR Ø3.5 SELF-TAP L26 TAN); 2X PART 412.109S, LOT 9706620 (LOCKSCR Ø3.5 SELF-TAP L26 TAN); 1X PART 412.109S, LOT 9743802 (LOCKSCR Ø3.5 SELF-TAP L26 TAN). THIS REPORT IS 1 OF 2 FOR (B)(4).
IT WAS REPORTED THAT THE UNKNOWN SCREW BROKE POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153060 | 2.7MM/3.5MM TI VA-LCP POSTLAT DHP/9H/LT/153MM-XLNG-STER | PLATE,FIXATION,BONE | HRS | SYNTHES RARON | 9329222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention |