MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW 48MM- FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	458.948
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
Patient height reported as 177 centimeters.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) 2019, the patient underwent a hardware removal of a trochanteric fixation nail (tfn) system due to non-union of the intertrochanteric fracture which was also converted into a right total hip.The distal screw was broken in the nail.The original date of implant was on (b)(6) 2016.It is unknown if there was a surgical delay.Procedure outcome was unknown.The patient experienced pain in the hip.Concomitant device reported: 11mm/130 degree ti cannulated troch fixation nail (part 456.420s, lot unknown, quantity 1); 11.0mm ti helical blade 95mm (part 456.304, lot unknown, quantity 1).This report is for a locking screw.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW 48MM- FOR IM NAILS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8621149
• Report Number: 2939274-2019-58159
• Device Sequence Number: 2129813
• Product Code: HWC
• UDI-Device Identifier: 10886982230935
• UDI-Public: (01)10886982230935
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: 458.948
• Device Catalogue Number: 458.948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/17/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11.0MM TI HELICAL BLADE 95MM; 11MM/130 DEGREE TFN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 74