MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 360MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.257S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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 history lot: manufacturing location: (b)(4), manufacturing date: 27-feb-2018, expiration date: 31-jan-2028, part number: 04.037.257s, 12mm/130 deg ti cann tfna 360mm/left- sterile, lot number: h574488 (sterile).Component part(s) reviewed: part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h474715, part number: 04.037.942.2, lock prong, 130 degree tfna, bp55, lot number: l691122, purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h551766, part number: 21127, timoagri16.00, bp80, lot number: h359475.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.(b)(4).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 or Problem Description
It was reported on (b)(6) 2019, it was a trochanteric femoral nail advanced (tfna) broke onto the proximal into the nail during an open reduction internal fixation (orif) femur - trochanteric femoral nail advance (tfna) revision procedure.The reason for the implantation was due to broken femur.The trochanteric femoral nail advance (tfna) nail broke proximally.The surgeon had to pull out the whole tfn and replaced it with new tfn.Case was fine.Patient was fine.Concomitant device reported: unknown tfna helical blade (part# unknown, lot# unknown, quantity# 1); unknown tfna end cap (part# unknown, lot# unknown, quantity# 1); unknown locking screws (part# unknown, lot# unknown, quantity# unknown) this report is for one (1) 12mm/130 deg ti cann tfna 360mm/left-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 360MM/LEFT-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8950578
• Report Number: 2939274-2019-60245
• Device Sequence Number: 11380294
• Product Code: HSB
• UDI-Device Identifier: 10886982097378
• UDI-Public: (01)10886982097378
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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
• Operator of Device: Health Professional
• Device Model Number: 04.037.257S
• Device Catalogue Number: 04.037.257S
• Device Lot Number: H574488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention