MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 90MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.290S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Date of event: unknown.Device has not been reported as explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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 that on (b)(6) 2018, open reduction internal fixation was applied to femoral trochanteric fractures.On (b)(6) 2018, the cut-out of trochanteric fixation nail advanced (tfna) helical blade in question was found.The surgeon commented that improper reduction might have caused this event.Concomitant device reported: 12mm/125 deg ti cann tfna 170mm ¿ sterile (part 04.037.212s, lot h285727, quantity 1).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.H3, h4, h6: a device history record (dhr) review was conducted for item: 04.038.290s, lot: h422230: mfg qty: 44, mfg date: 25 aug 2017, mfg location: elmira - machining / monument - finishing/packaging: product was inspected at inspect i and final inspection per ns065693, rev l.Inspection sheet indicates all required inspections were performed and product passed.There were no ncs or reworks generated during the manufacturing of this work order.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: a product investigation was conducted.Visual inspection performed at customer quality (cq) showed wear consistent with implantation and explantation.However, no damage that would contribute to the reported complaint condition was observed.The complaint device was received with the concomitant nail, which had no reported complaint condition and showed no evidence of contributing to the reported event.No x-rays/radiographs showing the reported migration condition were provided, therefore this complaint was not able to be confirmed.Functional test: a relevant functional test to replicate the reported complaint condition was not able to be performed at cq as this was a post-operative event.Document / specification review: the complaint device was manufactured in august 2017.The tabulated product design drawing for the family of titanium trochanteric fixation nail advanced (tfna) helical blades was reviewed during this investigation.No product design issues or discrepancies were observed.Dimensional inspection: the outside diameter of the helix at the start measured, which is within specification per tabulated product design drawing.The width of the helical blade at the locking mechanism flat measured, which was within specification.Conclusion: a root cause for the reported migration was not able to be determined based on the provided information.This complaint was not able to be confirmed based on the provided information.No product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: TFNA HELICAL BLADE 90MM STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7574632
• MDR Text Key: 110325816
• Report Number: 8030965-2018-54154
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652446
• UDI-Public: (01)07611819652446
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• 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: 05/16/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.290S
• Device Lot Number: H422230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention