MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.421S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Date of implant reported as (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Review of the device history record 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 or Problem Description
It was reported that a hardware removal and revision of a trochanteric fixation nail (tfn) was performed on (b)(6) 2017 due to a broken nail and non-union.The original procedure was performed in (b)(6) 2017.The removed hardware included: one (1) 11mm x 400mm tfn nail (broken below the hole for helical blade), one (1) intact helical blade and one (1) intact locking screw.It is noted that before the original procedure, the patient walked with a limp.Regarding the non-union, it was noted that the medial side of the original fracture showed healing, the lateral side of the original fracture did not.The hardware was removed without incident.The patient was revised to a new tfn construct.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: 11.0mm helical blade 105mm (456.306s, lot h045635, quantity 1), locking screw (part number unknown, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed: manufacturing location: (b)(4), manufacturing date: 15-feb-2017, expiration date: 31-jan-2026: part #: 456.421s, lot#: h294122 (sterile) - 11mm/130 deg ti cann troch fixation nail 400mm/left - sterile.Quantity 6.Component parts reviewed: 456.314.3 - trochanteric fixation nail lock driver tfn, bp 55, lot h226876, 456.315.2 - trochanteric fixation nail lock 130 deg lock prong tfn, bp 55, lot h258243, 21069 - raw material lot bp-80 lot - 9876154 received from supplier ati specialty materials.Ati allvac certificate of test for (b)(4) meets specification.Raw material receiving/putaway checklist meet specification.Inspection sheet for inprocess/inspect dimensional/final met inspection acceptance criteria.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.Sterility documentation was reviewed and determined to be conforming.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 TROCH FIXATION NAIL 400MM/LEFT-STER
• 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: 7184233
• Report Number: 2939274-2018-50174
• Device Sequence Number: 18865962
• Product Code: HSB
• UDI-Device Identifier: 10886982227874
• UDI-Public: (01)10886982227874(17)EXPIRATIONUNKNOWN(10)H294122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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 Expiration Date: 01/31/2026
• Device Model Number: 456.421S
• Device Catalogue Number: 456.421S
• Device Lot Number: H294122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention