MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GRAFT PUSHER 8MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	394.572
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the device handle chipped during a spinal fusion procedure to treat degenerative disc disease.No further information is available.This report is for one (1) graft pusher 8mm.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: investigation site: customer quality (cq) zuchwil.Selected flow: damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the inspection has shown that a small fragment of about 5mm length is broken off from the edge at the forefront of the handle.The fragment was not returned for evaluation.Otherwise is the device in a good condition with no visible damages.Dimensional inspection: the relevant dimensions cannot be verified anymore as the breakage occurred at the edge of the conical end of the handle.Drawing/specification review: the review of the manufacturing documents has shown that the lot in question had a lot size of (b)(4) pieces.The review of the complaint history has shown that there are no other complaints for this article- and lot combination registered.Investigation conclusion: the complaint is confirmed as a fragment is broken off from the handle as complained.During the performed evaluation no manufacturing related issue could be detected.Based on the provided information the exact cause of this occurrence cannot be defined.We can only assume that an unintended hit onto the edge of the handle did lead to this breakage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part number: 394.572; lot number: t186314; manufacturing site: tuttlingen; release to warehouse date: 04-sep-2019 ((b)(4) devices), 19-nov-2019 ((b)(4) devices), 20-dec-2019 ((b)(4) devices), 12-feb-2020 ((b)(4) devices), 09-mar-2020 ((b)(4) devices).A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: GRAFT PUSHER 8MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10368581
• Report Number: 8030965-2020-05635
• Device Sequence Number: 2301515
• Product Code: LXH
• UDI-Device Identifier: 07611819742161
• UDI-Public: (01)07611819742161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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: 394.572
• Device Lot Number: T186314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1