MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	04.168.280S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.The patient underwent a revision surgery on (b)(6) 2019 to remove the fns and reduce the subtrochanteric fracture with a nesplon cable.The surgeon fixed the fracture with a long nail, (zimmer biomet product).This report is for one (1) bolt for femoral neck system 80 mm length-sterile.(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 bone fracture below the femoral neck screw can be confirmed.Based on the provided information did the fracture occur on the during the implantation mistakenly drilled position, which is covered in complaint (b)(4).There is at this point no indication of a device malfunction.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 or material is made available, the investigation will be updated as applicable.Device history lot part: 04.168.280s, lot: 4l40083, manufacturing site: grenchen, release to warehouse date: apr.25, 2019, expiry date: apr.01, 2029.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: BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9444738
• Report Number: 8030965-2019-70971
• Device Sequence Number: 14017135
• Product Code: KTT
• UDI-Device Identifier: 10886982274724
• UDI-Public: (01)10886982274724
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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 Model Number: 04.168.280S
• Device Catalogue Number: 04.168.280S
• Device Lot Number: 4L40083
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR