MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.145S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: event occurred on an unknown date in 2020.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.Product was not returned.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) 2020, the patient underwent a revision surgery due to broken implant trochanteric fixation nail advanced (tfna) at blade nail junction and non-union.The implantation surgery wa performed on (b)(6) 2020.There was patient consequence reported.There was no surgical delay.Concomitant device reported: unknown helical blade: tfna(part# unknown; lot#: unknown; quantity: 1).Unknown locking screw (part#: unknown; lot# unknown: quantity: unknown).This report is for one (1) 11mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 235MM/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: 11165495
• Report Number: 2939274-2021-00286
• Device Sequence Number: 13677247
• Product Code: HSB
• UDI-Device Identifier: 10886982096579
• UDI-Public: 10886982096579
• Combination Product (Y/N): N
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 04.037.145S
• Device Catalogue Number: 04.037.145S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR