MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.226S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the patient will undergo a revision surgery due to a twice broken trochanteric fixation nail advance (tfna) nail at the aperture.Primary surgery was on (b)(6) 2018.It is unknown when the first breakage happened.The patient will be revised with a femoral recon nail (frn).Concomitant devices reported: 40mm locking screw (part# 04.005.530s, lot# l702526, quantity: unknown).46mm locking screw (part# 04.005.536s, lot# l694087, quantity: unknown).Tfna end cap (part# 04.038.000s, lot# l579683, quantity: 1).Unknown plate (part# unknown, lot# unknown, quantity:1).Unknown screw (part# unknown, lot# unknown, quantity:4).This complaint involves (1) device.This report is 1 of 1 for (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history review 10-dec-2018: dhr reviewed.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history manufacturing location: monument, manufacturing date: 19-oct-2017, expiration date: 01-oct-2027, part number: 04.037.226s, 12mm/125 deg ti cann tfna 360mm/right- sterile, lot number: h478712 (sterile), lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final ns063055 rev h met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label was reviewed and determined to be conforming.Scn supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Investigation summary - complaint is confirmed as we are able to confirm complaint description (broken nail) based on the received pictures.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.

• Brand Name: 12MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8143008
• MDR Text Key: 129648668
• Report Number: 8030965-2018-58846
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651081
• UDI-Public: (01)07611819651081
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.226S
• Device Lot Number: H478712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention