MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.359S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when the event occurred.(b)(4).Product investigation has not been completed; no conclusion could be drawn, as no product was received.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.No ncrs were generated during the production of this device.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 was performed on (b)(6) 2017.The patient was originally implanted with a trochanteric fixation nail, helical blade, and unknown screws on a unknown date.The patient subsequently experienced a non-union and these parts were removed.The removed devices were intact.The patient was revised to a plate.There was no surgical delay.No information regarding the patient status as well the procedure status was provided.This complaint involves three (3) parts.This report is for a nail.(b)(4).
Additional Manufacturer Narrative
Device history records (dhr) review was completed for part# 456.359s, lot# 6278678.Manufacturing location: (b)(4) , manufacturing date: dec 16, 2009, expiration date: nov 30, 2018.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.In-process inspection sheet, in-process/inspect dimensional, and final inspection met inspection acceptance criteria.Component parts reviewed: 456.314.3 - lock driver tfn, bp-55 lot ¿ 6162656; 456.315.2 - 130 degree lock prong tfn bp-58 lot - 6205461 21069 - raw material lot bp-80 lot ¿ 6136151 met specifications.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: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/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: 7175069
• Report Number: 2939274-2018-50123
• Device Sequence Number: 1812779
• Product Code: HSB
• UDI-Device Identifier: 10886982227317
• UDI-Public: (01)10886982227317(17)181130(10)6278678
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/12/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 456.359S
• Device Catalogue Number: 456.359S
• Device Lot Number: 6278678
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 01/31/2018
• 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 Age: 65 YR