MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS; SCREW,FIXATION,BONE

Model Number	04.005.524
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is reported as occurring within the year 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.(b)(4).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, patient underwent removal of one (1) titanium cannulated proximal femoral nailing system (tfna), one (1) titanium locking screw, one (1) tfna helical blade and one (1) tfna end cap because the femur broke below where these implants sat.Implants were originally implanted on (b)(6) 2020.She was initially seen for an intertrochanteric hip fracture.All implants are successfully removed and were revised to a long tfna and were also augmented fixation with a trauma cement.The patient outcome was successful with no concerns.Concomitant devices reported: 11mm/130 deg ti cann tfna 170mm ¿ sterile (part number 04.037.142s, lot unknown, quantity 1), tfna helical blade 90mm (part number 04.038.290, lot unknown, quantity 1), end caps: tfna (unknown part number, unknown lot, quantity 1).This report involves one (1) 5.0mm ti locking screw w/t25 stardrive 34mm for im nails.This is report 2 of 4 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM 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: 9953384
• Report Number: 2939274-2020-01806
• Device Sequence Number: 14102423
• Product Code: HWC
• UDI-Device Identifier: 10886982085924
• UDI-Public: (01)10886982085924
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.524
• Device Catalogue Number: 04.005.524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 68