MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 200MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.243S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of postoperative nail breakage is unknown.Complainant part is not expected to be 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 a patient underwent an intramedullary nail of the left hip on (b)(6) 2016, after patient experienced a fall and broke her left hip on an unknown date.The patient had a chronic non-union due to a malignant lesion.The internal nail broke through the distal locking screw on an unknown date.The patient underwent hardware removal on (b)(6) 2018.The synthes trochanteric fixation nail advance (tfna) was removed completely with no remaining hardware left behind.All removed hardware was intact except for the (tfna) nail.There was no surgical delay reported.The patient was stable.Concomitant device reported: helical blade (part #04.038.320s, lot # unknown, quantity # 1) locking screw (part # 458.944, lot # unknown, quantity # 1).This report is for one (1) tfna nail.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 200MM - 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: 7907286
• Report Number: 2939274-2018-53956
• Device Sequence Number: 19228924
• Product Code: HSB
• UDI-Device Identifier: 10886982097279
• UDI-Public: (01)10886982097279
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2018

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 Model Number: 04.037.243S
• Device Catalogue Number: 04.037.243S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2018
• Initial Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 76