SLIDING MECHANISM
Report
- Report Number
- 2939274-2018-53580
- Event Type
- Injury
- Date Received
- September 5, 2018
- Date of Event
- August 16, 2018
- Report Date
- August 16, 2018
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HTD
- UDI-DI
- 10886982188779
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: PATIENT HEIGHT REPORTED AS 4¿9¿ PART: 314.291 LOT: 150531-A02 MANUFACTURING SITE: SELZACH SUPPLIER: LEITNER AG RELEASE TO WAREHOUSE DATE: 20. APR. 2016 THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 25 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE SLIDING MECHANISM CAME UNDONE AND BROKE INTO TWO PIECES. THE REPAIR TECHNICIAN REPORTED THE HANDLE WAS BROKEN IN TWO PIECES AT THE SCREW. HANDLE CRACKED/BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. CUSTOMER QUALITY INVESTIGATION: INVESTIGATION FLOW: BROKEN & FUNCTIONAL: DEVICE CONDITION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY OBSERVED THAT THE SLIDING MECHANISM¿S HANDLE WAS BROKEN AT THE DISTAL ATTACHMENT SCREW. BROKEN FRAGMENTS OF THE HANDLE WERE NOT RETURNED. FURTHERMORE THE BLACK CASING COVER THAT COVERS THE SPRING MECHANISM WAS MISSING. NO FURTHER ISSUES WERE IDENTIFIED ON THE REMAINING PORTIONS OF THE DEVICE EXCEPT FOR THE SIGNS OF WEAR THAT DOESN'T AFFECT PRODUCT FUNCTIONALITY. FUNCTIONAL INSPECTION PERFORMED ON THE DEVICE SHOWED NO LOOSE COMPONENTS/PORTION BOTH ON THE TIP AND THE CLAMP LEVER ASSEMBLY PROXIMAL TO HANDLE. WITH THE BREAKAGE IDENTIFIED ON THE HANDLE PORTION, THE COMPLAINT CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT WAS CONFIRMED. DIMENSIONAL ANALYSIS AND DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWINGS FOR THE RETURNED DEVICE (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE): TOP-LEVEL AND HANDLE WERE REVIEWED. DIMENSIONAL INSPECTION WAS NOT POSSIBLE AT RELEVANT HANDLE PORTION, DUE TO THE POST MANUFACTURING DAMAGE.FURTHERMORE, TO ADDRESS THE LOOSE CONDITION DIMENSIONAL ANALYSIS PERFORMED ON THE FEED ROD MEASURED THE WIDTH AND THICKNESS AS 9.99 MM AND 6.98 MM THAT FALLS WITHIN THE SPECIFICATION OF 9.978 MM TO 10 MM AND 6.97 MM TO 7.0 MM RESPECTIVELY PER FEED ROD DRAWING. THE DEVICE HISTORY RECORD STATED THAT THIS LOT OF 25 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THE LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. FURTHERMORE, THE MATERIAL WAS REVIEWED, AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. ALSO, THE DCRM DOCUMENT REVIEWED DURING THE INVESTIGATION SHOWED THAT THE DOCUMENT COMPLETELY ADDRESSES THE COMPLAINT CONDITION. WHILE NO LOOSENED PORTIONS WERE IDENTIFIED ON THE RETURNED DEVICE, DEVICE BEING DROPPED AS STATED IN THE EVENT DESCRIPTION WAS IDENTIFIED TO BE THE ROOT CAUSE FOR THIS COMPLAINT CONDITION. CONCLUSION: THE OVERALL COMPLAINT CONDITION WAS CONFIRMED; HOWEVER, NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE 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.
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 ON (B)(6) 2018, THAT THE SLIDING MECHANISM SEPARATED AND BROKE INTO TWO (2) PIECES WHEN IT HIT THE FLOOR. THIS OCCURRED DURING AN UNKNOWN PROCEDURE. THE SURGEON'S HAND BUMPED THE CLAMP CAUSING IT TO LOOSEN AND HIT THE FLOOR. THE DEVICE WAS THEN UNUSABLE. THE SURGERY WAS COMPLETED USING OTHER CLAMPS. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 689828 | SLIDING MECHANISM | FORCEPS | HTD | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 150531-AO2 | 10886982188779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |