MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FEM NAIL 10 LE 130 L380 TIMO15; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.059S

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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 reports an event in (b)(6) as follows: it was reported that a broken tfna nail was removed and replaced with a proximal femoral plate.The surgeon reported non-union of the femur due to the lack of bone around the nail.The patient was able to walk on it for a year before the nail broke.The device was originally implanted on an unknown date in (b)(6) 2018.No further information provided.Concomitant device reported: tfna helical blade (part # 04.038.385s , lot # h667651, quantity# 1); unknown tfna end cap (part # unknown, lot # unknown, quantity# 1); unknown locking screw (part # unknown, lot # unknown, quantity# unknown).This report is for one (1) tfna fem nail 10 le 130 l380 timo15.This is report 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.H11: b1, b2, b5, h1: the initial complaint was reviewed and found not reportable.It was determined this complaint was a duplicate of a previously reported complaint and was already reported on manufacturer report number 8030965-2020-00238.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

The initial complaint was reviewed and found not reportable.It was determined this complaint was a duplicate of a previously reported complaint and was already reported on manufacturer report number 8030965-2020-00238.

• Brand Name: TFNA FEM NAIL 10 LE 130 L380 TIMO15
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9530868
• MDR Text Key: 173095350
• Report Number: 8030965-2019-71538
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650114
• UDI-Public: (01)07611819650114
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.059S
• Device Lot Number: H052636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Patient Sequence Number: 1
• Treatment: TFNA HELICAL BLADE PERF L85 TAN; UNK - END CAPS: TFNA; UNK - SCREWS: LOCKING; TFNA HELICAL BLADE PERF L85 TAN; UNK - END CAPS: TFNA; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention