MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.357S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hip Fracture (2349)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complainant part has not been returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 the patient underwent revision surgery for removal of a broken 10mm/130 deg ti cann troch fixation nail 360mm/left-ster on (b)(6) 2017.Initially the patient fell and fractured her hip, for which a 10mm/130 deg ti cann troch fixation nail 360mm/left-ster was implanted in (b)(6) 2017.The patient suffered from seizure and fainting disorders and on account of this she sustained another fall breaking her nail through the helical blade hole in the nail.The broken nail was removed during the revision surgery without incident along with an intact helical blade and two intact unknown locking screws.The femur was reamed to a larger size and an 11x360, 125 degrees, left tfn was implanted successfully.There was no surgical delay and the patient was stable after the surgery.Concomitant medical products: unk - nail head elem: tfn helical blade (part # unknown, lot # unknown, qty # 1), unk - screws: locking: trauma (part # unknown, lot # unknown, qty # 2).This complaint involves one (1) device.This report is for a nail.This is report 1 of 1 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/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: 7210344
• Report Number: 2939274-2018-50357
• Device Sequence Number: 16393294
• Product Code: HSB
• UDI-Device Identifier: 10886982227294
• UDI-Public: (01)10886982227294(10)UNKNOWNLOT
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 12/31/2017

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 Model Number: 456.357S
• Device Catalogue Number: 456.357S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2017
• Initial Report FDA Received Date: 01/22/2018
• 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: 50 YR
• Patient Weight: 88