MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.476S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional classification code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was requested.Patient code: surgical intervention was necessary to remove collapsed nail.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 or Problem Description
It was reported that a patient had a removal and revision surgery on (b)(6) 2018.The patient was initially implanted with (1)12mm/130 deg ti cann troch fixation nail 360mm/right, one (1) 11.0mm ti helical blade and one (1) distal locking screw on an unknown date.The surgeon removed the nail on (b)(6) 2018 due to the nail collapsing and the patient was revised to a cement bipolar nail implant.The removal procedure was completed successfully without any surgical delay.The patient had a less than desirable treatment outcome due to the nail collapsing, but was reported to be fine at the end of the procedure.Concomitant device (s) reported: 11.0mm ti helical blade 95 mm (part # 456.304, lot # h0283791), unknown distal locking screw (unknown part and lot number, qty # 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Manufacturing location: (b)(4), manufacturing date: 18-apr-2016, expiration date: 31-mar-2025 , part #: 456.476s, lot#: h077928 (sterile) - 12mm/130 deg ti cann troch fixation nail 360mm/right - sterile.Quantity 6.Component parts reviewed: 456.314.3 - lock driver tfn, bp 55, lot: h039386 , 456.315.2 - 130 deg lock prong tfn, bp 58, 9907973 , 21069 - raw material lot bp-80 lot - 9857068 received from ati, certificate of test received from ati specialty materials meet certificate of test specification for titanium.Raw material receiving/putaway checklist meet specification.Inspection sheet for inspect / inspect dimensional / final inspection meet specification.No 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.
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.Additional narrative: device is a single use device but was not reprocessed or reused.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 TROCH FIXATION NAIL 360MM/RIGHT
• 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: 7396704
• Report Number: 2939274-2018-51438
• Device Sequence Number: 18858452
• Product Code: HSB
• UDI-Device Identifier: 10886982228369
• UDI-Public: (01)10886982228369(17)250331(10)H077928
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2018

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: 03/31/2025
• Device Model Number: 456.476S
• Device Catalogue Number: 456.476
• Device Lot Number: H077928
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/25/2018; 04/13/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/07/2018; 05/10/2018
• 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
• Patient Weight: 76