MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CHISEL BLADE 25MM WIDTH-LONG; CHISEL, SURGICAL INSTRUMENT

Catalog Number	399.575
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.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 (b)(6) reports an event as follows: it was reported that during loan kit inspection on an unknown date, the following was discovered.Chisel blade - wedge end damaged and worn.Retractor - wedge end damaged and worn.This report is for a chisel blade 25mm width-long.This is report 1 of 2 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.A review of the device history record.Device history lot.Part number: 399.575, lot number: t966630, manufacturing site: tuttlingen, release to warehouse date: 04-jul-2011.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Investigation summary investigation site: cq zuchwil selected flow: damaged: visual | examples: deformed/bent/cracked/broken visual inspection: there is a round fragment of about 2 mm length broken off at the cutting edge of the received chisel blade.The fragment was not returned for evaluation.Otherwise is the chisel is a good condition, the cutting edge is sharp with no visible damages.Dimensional inspection: the review of the complaint history has shown that this is the first complaint for part 399.575, based on that a design related issue can be excluded.Summary: the complained breakage can be confirmed as a fragment is broken off.The complained wear cannot be confirmed, the cutting edge is sharp as required.During the investigation no manufacturing related issue could be detected.The device was manufactured in july 2011 and we are not aware of any other complaint for the affected lot t966630.There was no information provided how or when the breakage occurred, therefore the exact root cause cannot be defined.The round appearance of the breakage could be an indication for an metallic contact, for example a with a guide wire.Such a contact could cause a mechanical overload and finally the breakage in the contact area.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 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: CHISEL BLADE 25MM WIDTH-LONG
• Common Device Name: CHISEL, SURGICAL INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8854841
• Report Number: 8030965-2019-66782
• Device Sequence Number: 2515530
• Product Code: FZO
• UDI-Device Identifier: 07611819498075
• UDI-Public: (01)07611819498075
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: 399.575
• Device Lot Number: T966630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1