MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.157S
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.(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 that on (b)(6) 2019, the patient underwent a revision of trochanteric fixation nail advanced (tfna).The trochanteric fixation nail advanced (tfna) was broken, the sales consultant was called to assist with the removal and revision of the device.There was a non union on the postoperative event.There was no suggestion by anyone indicating that there was or maybe deficiency with the product.The device was explanted.Fragments were generated due to the broken device, the removal of the broken, damaged device or fragments was easily removed.There was no surgical delay.The procedure and patient outcome were successfully completed.Concomitant device reported: unknown lag screw (part # unknown, lot # unknown, quantity 1), unknown nail head (part # unknown, lot # unknown, quantity 1), unknown locking screws (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) 11 mm/130 deg ti cann tfna 360 mm/left - sterile.This is report 1 of 1 for (b)(4).
Additional 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.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.
Additional 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.Device history lot.Manufacturing location: monument, manufacturing date: 24-feb-2017, expiration date: 31-jan-2027, part number: 04.037.157s, 11mm/130 deg ti cann tfna 360mm/left- sterile, lot number: h303366 (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: 04.037.942.2, lock prong, 130 degree tfna, bp55, lot number: l220182, part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h045967, part number: 04.037.912.3, tfna lock drive, bp58, lot number: h228204, part number: 21127, timoagri16.00, bp80, lot number: h145473.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.

• Brand Name: 11MM/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: 8982785
• Report Number: 2939274-2019-60423
• Device Sequence Number: 3274925
• Product Code: HSB
• UDI-Device Identifier: 10886982096654
• UDI-Public: (01)10886982096654
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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,Followup,Followup
• Report Date (Section B): 08/13/2019

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: 04.037.157S
• Device Catalogue Number: 04.037.157S
• Device Lot Number: H303366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 10/01/2019; 10/01/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/07/2019; 10/09/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE; UNK - SCREWS: LOCKING; UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Weight: 64