MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HAMMER GUIDE

Catalog Number	357.071
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 a procedure on (b)(6) 2020, there were problems removing the proximal femoral nail antirotation (pfna).The extraction screw and hammer guide became twisted.Fragments were generated but were easily removed.Different instruments were used to complete the case.The procedure was completed successfully with a delay of three hundred and sixty (360) minutes.Patient status is unknown.Concomitant devices: pfna nail (part: unknown, lot: unknown, quantity: 1), pfna blade (part: unknown, lot: unknown, quantity: 1), hammer guide (part: 357.071, lot: unknown, quantity: 1).This report is for (1) hammer guide.This is report 1 of 1 (b)(4).Related product 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.Narrative (breakage) couldn't be verified from the provided pictures, but it's visible that threads of the hammer guide are worn, based on this the complaint is confirmed.Product was not returned therefore no further investigation possible.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 (information or/and material), 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.

• Brand Name: HAMMER GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10521440
• Report Number: 8030965-2020-06842
• Device Sequence Number: 3118209
• Product Code: FZX
• UDI-Device Identifier: 07611819073609
• UDI-Public: (01)07611819073609
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 08/12/2020

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: 357.071
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACTSCR F/PFNA BLADE; UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - NAILS: PFNA