MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH INSERT HANDLE; APPLIANCE,FIXATION,NAIL

Catalog Number	03.168.008
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a synthes employee.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.(b)(4).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 on (b)(6) 2019, the patient underwent an open reduction internal fixation surgery for the right femoral neck fracture with femoral neck system (fns).While drilling the locking screw the surgeon drilled through the ¿2 hole plate¿ of the insertion handle in error.He drilled then through the ¿1 hole plate¿ of the insertion handle and inserted a locking screw.The surgery was delayed by less than 30 minutes.On (b)(6) 2019, the hospital reported that the patient got a subtrochanteric fracture on the mistakenly drilled position (reported in (b)(4)).The patient will undergo a revision surgery with artificial bone and afn.Concomitant devices: unknown drill (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) insert handle.(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.The received x-rays were reviewed, the described occurrence with using the incorrect 2-hole set up of the insertion handle can be confirmed as there is an unoccupied hole below the locking screw visible in the bone.Based on the provided information is there no allegation against the insertion handle as this was an user error.Therefore no further investigation on the handle is required.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.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.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: INSERT HANDLE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9411466
• Report Number: 8030965-2019-70748
• Device Sequence Number: 16877536
• Product Code: KTT
• UDI-Device Identifier: 07611819657342
• UDI-Public: (01)07611819657342
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172872
• 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): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.168.008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 01/21/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/15/2020; 02/03/2020
• 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: UNK - POWERED DRIVERS/HANDPIECES; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR