T-HANDLE INSERTER
Report
- Report Number
- 3013730328-2021-00010
- Event Type
- Malfunction
- Date Received
- April 29, 2021
- Date of Event
- April 1, 2021
- Report Date
- April 6, 2021
- Manufacturer
- EIT EMERGING IMPLANT TECHNOLOGIES GMBH
- Product Code
- MAX
- UDI-DI
- 04260397088388
- PMA / PMN Number
- K172888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
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: INVESTIGATION SUMMARY. VISUAL INSPECTION: THE T-HANDLE INSERTER (P/N: PET30101, LOT #: E19DI1385) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE LASER WELD OF THE PET30101 B PLIF INSERTER PIN WAS BROKEN. THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED PET30101 T-HANDLE INSERTER SH CONNECTION. PET30101 B PLIF INSERTER PIN. PET30102-01 EIT PLIF INSERTER CONNECTING ROD. COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED WAS BROKEN. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS CONFIRMED FOR THE T-HANDLE INSERTER (P/N: PET30101, LOT #: E19DI1385). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: 510K: ADDITIONAL CODE K170503. DEVICE HISTORY LOT PART NUMBER:PET30101. SYNTHES LOT NUMBER: E19DI1385. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: 05NOV2020. EXPIRATION DATE: N/A. SUPPLIER: EIT. NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: BACKGROUND. CAGE COULD NOT BE DISCONNECTED FROM THE CAGE HOLDER. CAGE HOLDER ALSO BROKEN AT THE DISTAL END OF THE INSTRUMENT. INSTRUMENT AND CAGE WERE REMOVED AND REPLACED BY ANOTHER INSTRUMENT AND CAGE. SURGERY DELAY: 10MIN. NO ADVERSE PATIENT HARM. SURGERY COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES TWO (2) DEVICES. CUSTOMER QUALITY INVESTIGATION: THE INSTRUMENT(S) WAS NOT RETURNED, AND THE INVESTIGATION WILL BE COMPLETED BASED ON THE SUPPLIED IMAGE(S) LOCATED IN PC'S ATTACHMENTS SECTION RECEIVED THROUGH 06APR2021.THE IMAGE(S) WAS REVIEWED, AND THE COMPLAINT CONDITION OF "UNABLE TO DISASSEMBLED" WAS CONFIRMED, AS IT APPEARS THE CAGE IS SEIZED ON THE INSTRUMENT AND WILL NOT DETACH. THE BROKEN CONDITION COULD NOT BE CONFIRMED AS AN IMAGE OF THE ENTIRE INSTRUMENT WAS NOT PROVIDED. AS THE INSTRUMENT(S) WAS NOT RETURNED AND AS RECEIVED, DIMENSIONAL, MATERIAL OR DRAWING REVIEWS ARE NOT APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO ISSUES WERE NOTED. CONCLUSION: THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT AS THE CIRCUMSTANCES DURING THE TIME OF THE EVENT ARE UNKNOWN. NO NEW MALFUNCTIONS WERE OBSERVED DURING THIS INVESTIGATION (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CAGE COULD NOT BE DISCONNECTED FROM THE CAGE HOLDER. THE CAGE HOLDER ALSO BROKEN AT THE DISTAL END OF THE INSTRUMENT, THE INSTRUMENT AND CAGE WERE REMOVED AND REPLACED BY ANOTHER INSTRUMENT AND CAGE. THERE WAS A SURGERY DELAY OF 10MIN. NO ADVERSE PATIENT HARM AND SURGERY WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES TWO (2) DEVICES(1). THIS REPORT IS FOR ONE (1) T-HANDLE INSERTER. THIS REPORT IS 1 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 641099 | T-HANDLE INSERTER | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | EIT EMERGING IMPLANT TECHNOLOGIES GMBH | PET30101 | E19DI1385 | 04260397088388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | POST IBF HI H 9MM 4DEG 26/9| T-HANDLE INSERTER |