MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/135 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.172S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history lot: manufacturing location: (b)(4), manufacturing date: 21-aug-2017, expiration date: 31-jul-2027, part number: 04.037.172s, 11mm/135 deg ti cann tfna 170mm- sterile, lot number: h431718 (sterile).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.Component parts reviewed: part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h249498, part number: 04.037.972.2, lock prong, 135 degree tfna, bp55, lot number: l468088, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h386841, part number: 21127, timoagri16.00, bp80, lot number: h152653.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.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 that on (b)(6) 2019, the patient underwent a removal of short trochanteric femoral nail advanced (tfna) and helical blade due to nonunion visible on x-rays 9 weeks post-operative and delayed healing.The surgeon said that the implant was too small for his femur and had to go to a long tfna.During revision, the short tfna was discovered broken intra-operatively at the junction of the tfna nail and helical blade.Fragments were easily removed.There was no surgical delay.Procedure outcome was successfully completed.Patient outcome was unknown.Concomitant device reported: helical blade (part # unknown, lot # unknown, quantity # 1); locking screw (part # unknown, lot # unknown, quantity # 1).This report is for one (1) 11mm/135 deg ti cann tfna 170mm - sterile.This is report 1 of 1 for (b)(4).This (b)(4) captures post-op event involving a nonunion and broken tfna nail, while (b)(4) captures intra-op event involving a helical blade that was hard to implant.

• Brand Name: 11MM/135 DEG TI CANN TFNA 170MM - 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: 8654541
• Report Number: 2939274-2019-58380
• Device Sequence Number: 11220609
• Product Code: HSB
• UDI-Device Identifier: 10886982096784
• UDI-Public: (01)10886982096784
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 04.037.172S
• Device Catalogue Number: 04.037.172S
• Device Lot Number: H431718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/30/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention