MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRIVER FOR DETACHABLE TEMPORARY FIXATION PIN; MISC ORTHO SURGICAL INSTR

Catalog Number	389.872
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This patient¿s information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during l5/s1 anterior lumbar interbody fusion (alif) surgery, the driver for detachable temporary fixation pin broke while removing fixation pin from patient.The surgeon used forceps to remove broken tabs.There was five (5) minute of surgical delay.It is unknown if the procedure was completed successfully.Patient outcome is fine.Concomitant device reported: unknown fixation pin (part# unknown, lot# unknown, quantity# 1).This report is for one (1) driver for detachable temporary fixation pin.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
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.H3, h6: the subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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.
Additional Manufacturer Narrative
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.Part: 389.872; synthes lot: 4877090; supplier lot: 545254k04; release to warehouse date: october 25, 2004; manufacturing site: synthes monument; supplier: beere precision medical instruments no nonconformance reports (ncrs) were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The implant was received with the reported condition of ¿broken (2+ pieces) intraoperatively: rm¿ the following investigation flow was performed: broken it was visually observed that one of the distal flanges has broken off from the instrument, the broken portion was not returned.The balance of the instrument is in fair condition.The complaint condition is confirmed and the received condition agrees with the complaint description.The cause of the issue could not be definitively traced to use error, misuse/abuse, non-compliance, postoperative trauma.Dimensional inspection: diameter specification: ø 6.35 +/- 0.1 mm.Measured diameter: ø 6.25 mm; conforming.Device used: calipers ca215p.A device history review, was performed for the returned implant¿s lot number and no material review reports (mrrs), ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.A review of the current design drawing and the drawing revision at the time of manufacture was performed: no issues were identified.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.It is possible that an excessive off-axis load was applied resulting in the complaint condition.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.

• Brand Name: DRIVER FOR DETACHABLE TEMPORARY FIXATION PIN
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7806810
• Report Number: 8030965-2018-55903
• Device Sequence Number: 11062197
• Product Code: LXH
• UDI-Device Identifier: 07611819775992
• UDI-Public: (01)07611819775992
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 389.872
• Device Lot Number: 4877090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/28/2018; 09/28/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/17/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1