MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12/130 DEG TI CANN TFNA 440/LEFT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.265S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2021 the patient underwent revision surgery due to the non-union, broken nail.On (b)(6) 2020, this patient underwent open reduction internal fixation of a sub-trochanteric femur fracture.A long proximal femoral nailing system (tfna) nail, helical blade, and locking screw were inserted.Subsequently, the fracture went on to non-union, and the tfna nail broke at the helical blade aperture.The patient was brought back to the operating room on (b)(6) 2021.Tfna nail, helical blade, and locking screw were removed without any difficulty and a 95 degree angled blade plate was inserted.The fracture was reduced, and compressed by means of the articulated tensioner device.No surgical delay has been reported.This report is for one (1) 12mm 130 degree tfna nail.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 12/130 DEG TI CANN TFNA 440/LEFT-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: 11718507
• Report Number: 2939274-2021-02050
• Device Sequence Number: 3192388
• Product Code: HSB
• UDI-Device Identifier: 10886982097453
• UDI-Public: (01)10886982097453
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 04.037.265S
• Device Catalogue Number: 04.037.265S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 TI LCKNG SCR T25 SD 72 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 72 FOR IM NAILS; TFNA FENESTRATED SCREW 105MM; TFNA FENESTRATED SCREW 105MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR