MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.528
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Only event year is 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.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 showed in the office complaining of hip pain and it was thought that she had fallen.The x-ray showed that the proximal femoral nailing system (tfna) that was implanted on (b)(6) 2020, had cut out.The procedure was successfully completed.Patient consequence total hip replacement.Concomitant devices reported: 12mm/130 deg ti cann tfna 235mm/right ¿ sterile (part number 04.037.244s, lot 34p7508, quantity 1), tfna fenestrated screw 95mm ¿ sterile (part number 04.038.195s, lot h359691, quantity 1).This report involves 1 5.0mm ti locking screw w/t25 stardrive 38mm for im nails.This is report 3 of 3 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM 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: 11050250
• Report Number: 2939274-2020-05672
• Device Sequence Number: 16971900
• Product Code: HWC
• UDI-Device Identifier: 10886982085962
• UDI-Public: (01)10886982085962
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: 04.005.528
• Device Catalogue Number: 04.005.528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/21/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12MM/130 DEG TI CANN TFNA 235MM/R; TFNA FENESTRATED SCREW 95MM
• Outcome Attributed to Adverse Event: Required Intervention