MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II Ø10 LONG R 125° L300 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 473.015S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a synthes employee.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 Description

Device report from (b)(6) reports an event as follows: it was reported that in (b)(6) 2018 the patient underwent an implant surgery for a femoral subtrochanteric fracture with proximal femoral nail antirotation (pfna) and the screw in question.Approximately six (6) months after the surgery the distal screw broke.The patient did not have a revision surgery and the fracture didn¿t unite.In (b)(6) 2019, the nail broke at the fracture part due to non-union and the patient underwent a successful revision operation.The surgeon commented that the patient was elderly female and the fracture was atypical fracture, and it caused non-union and the breakage of the nail.The surgeon thought that there was no product defect.Concomitant device reported: unknown pfna-ii blade (part# unknown, lot# unknown, quantity# 1).Bolt ((part# 459.340vs, lot# 5939410, quantity# 1).This report is linked to pc-(b)(4) and pc-(b)(4).

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: PFNA-II Ø10 LONG R 125° L300 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9516699
• MDR Text Key: 189079316
• Report Number: 8030965-2019-71432
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 473.015S
• Device Lot Number: L643857
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2019
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention