MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH COMBINED HAMMER; HAMMER,SURGICAL

Catalog Number	359.221
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, during an unknown surgery that the hammer broke during hammering.There was no surgical delay.Patient and procedure outcome were unknown.This report involves one (1) combined hammer.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.H3, h6: the device has been 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
It was further reported that the procedure was successfully completed.
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: a product investigation was conducted.Reviewing received picture, the complaint description can be confirmed that some metal pieces blow out of the hammering surface.Visual inspection: the received combined hammer is in a desolate condition.The slot handle is marked from heavy hammer blows.Further evaluation has shown that at the edges of the hammering surface some metal pieces are blow out.Dimensional inspection: the relevant features are heavy damaged in a manner which prevents accurate measurement of the features.The damages are clearly caused post manufacturing.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.This combined hammer was made from the sub-component hammering body (50128268).The component is not lot tracked.Therefore, the last three potential work orders that were produced prior to lot 1l60852 were reviewed.The review has shown that with raw materials 1.4034 the correct material was used.The measurements of the hardness after the hardening procedure were within the specification per relevant drawing.Summary: the complaint condition is confirmed due to the damages found on the devices.The instrument is in a desolate condition and is marked from heavy hammer blows.On the lower section of the hammer head a part of the hammering surface is chipped off.From the signs of usage it could be assumed that the hammer head has been used more on one side than the other.We assume that the chipping of the metal part from the hammer head could be caused by hitting with the edge of the hammer head on the hammer guide for ten (359.218).However, based on the findings above no fault could be found in material or during the production.This failure is typically consistent with inadequate handling of the device in combination with high excessive force application.During the investigation, no product design or manufacturing issues were observed 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 as no product related issue could be detected.H3, h4, h6: a device history record (dhr) review was conducted: part: 359.221, lot: 1l60852, manufacturing site: umkirch, release to warehouse date: 20 sep 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: COMBINED HAMMER
• Common Device Name: HAMMER,SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10174056
• Report Number: 8030965-2020-04325
• Device Sequence Number: 2464616
• Product Code: FZY
• UDI-Device Identifier: 07611819096660
• UDI-Public: (01)07611819096660
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2020

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: 359.221
• Device Lot Number: 1L60852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 07/30/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/22/2020; 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1