MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 10MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.042S

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Explant of device was not reported.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.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 synthes europe reports an event in (b)(6) as follows: it was reported patient was implanted with the trochanteric femoral nail-advanced (tfna) on (b)(6) 2017 for a right femoral trochanteric fracture.Surgery was completed with a delay of approximately 15 minutes and no adverse consequence to patient.It is not known what caused the delay.Postoperative x-ray confirmed the shade of a protruding object.Surgeon noted the protruding object may be a bent portion of the short nail implanted, which may have been created by the excessive force used to detach the instrument from the short nail.(b)(4).

Manufacturer Narrative

Device history records review was completed for part# 04.037.042s, lot# 9925489.Manufacturing location: (b)(4), manufacturing date: oct 23, 2015, expiry date: oct 31, 2025.Part #: 04.037.042s, lot#: 9925489 (sterile) - 10mm/130 deg ti cann tfna 170mm - sterile.Quantity 6.Component parts reviewed: part 04.037.942.2 - lock prong, 130 degree, tfna bp-55 lot - 9432263, part 04.037.912.4 - wave spring, shim ended bp-55 lot - 7840803, part 04.037.912.3 - tfna lock drive bp-58 lot - 9893722, part 21127 - raw material lot bp-80 lot - 9909051.Raw material received from supplier (b)(4).Certified test report received from (b)(4) for titanium and certificate of analysis received from (b)(4).Meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet for in-process/inspect dimensional/final and inspection sheet for tfna assembly inspection met inspection acceptance criteria.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Complaint is confirmed as complaint description could be confirmed based on the received pictures/x-rays.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: 10MM/130 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7181005
• MDR Text Key: 96963266
• Report Number: 8030965-2018-50253
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649941
• UDI-Public: (01)07611819649941(17)251031(10)9925489
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.042S
• Device Lot Number: 9925489
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1