MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.242S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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

It was reported that on (b)(6) 2018, patient underwent a removal of a trochanteric fixation nail advanced (tfna) due to a fracture that occurred at a point of a stress riser between the tfna nail and a variable angle (va) condylar plate.The tfna nail was easily removed and replaced with a new, longer tfna nail which extended beyond the plate.An unknown quantity of cables were also placed to augment the construct, as well as an unknown quantity of screws.No fragments were produced.It is not known if surgery was delayed.Patient outcome is not known.This report is for one (1) 12mm 130 degree cannulated tfna nail this is report 1 of 5 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.Manufacturing location: monument; manufacturing date: december 14, 2017; expiration date: november 30, 2027; part: 04.037.242s, 12mm/130 deg ti cann tfna 170mm - sterile lot: h522586 (sterile); lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label logs lppf were reviewed and determined to be conforming.Packaging bom was reviewed and all components issued met current documented requirements.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: part: 04.037.912.4 - wave spring, shim ended bp-55 lot: h474689; lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Material certification and certificate of conformance and quality history cards supplied by (b)(4) dated november 02, 2017 were reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Part number: 04.037.942.2 - lock prong, 130 degree, tfna bp-55 lot: l643484; lot quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Part: 04.037.912.3 - tfna lock drive bp-58 lot: h493996; lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part: 21127 timoagri16.00 bp-80 lot: h305635; lot quantity: (b)(4).Certificate of analysis supplied by metalwerks dated december 08, 2016 was reviewed and determined to be conforming.Lot summary report dated february 21, 2017 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12MM/130 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7782538
• MDR Text Key: 117128362
• Report Number: 2939274-2018-53326
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097262
• UDI-Public: (01)10886982097262
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.037.242S
• Device Catalogue Number: 04.037.242S
• Device Lot Number: H522586
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR