MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 95MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.095
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient weight not available for reporting.Date of non-union is not known.Date of implant is not known.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 had to undergo a revision orif surgery on (b)(6) 2018 due to non-union.Initially the patient had an orif of subtrochanteric femur fracture which was fixed with a synthes trochanteric fixation nail advanced (tfna) screw 95mm, 5.0mm ti locking screw w/t25 stardrive 40mm for im nails and 11mm/130 deg ti cann tfna 400mm/right - sterile on an unknown date.During the revision surgery one (1) tfna screw 95mm, one (1) 5.0mm ti locking screw w/t25 stardrive 40mm for im nails and one (1) 11mm/130 deg ti cann tfna 400mm/right - sterile were all removed successfully and were not broken.The patient was implanted with a synthes dynamic hip screw system (dhs) plate, large screw and cortex screws to address the non-union.The procedure was successfully completed without any delay.The patient was stable after the surgery.This report is for one (1) tfna screw 95mm.(b)(4).

• Brand Name: TFNA SCREW 95MM
• 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: 7363549
• Report Number: 2939274-2018-51184
• Device Sequence Number: 11081190
• Product Code: HSB
• UDI-Device Identifier: 10886982098481
• UDI-Public: (01)10886982098481(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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
• Report Date (Section B): 02/23/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.038.095
• Device Catalogue Number: 04.038.095
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/22/2018
• 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: 63 YR