MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 11; SCREW,FIXATION,BONE

Model Number	02.214.111
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review /investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, patient underwent a hand surgery procedure.Initial injury was sustained from a gunshot wound to the hand.While inserting 1.5mm x 11mm cortex screws during an orif of a metacarpal, the surgeon had 4 screws brake/strip.One screw was removed.One was implanted, but the head is stripped.Two screws had their head break off while being implanted.The surgeon was unable to remove the shaft of the 2 broken screws, they remained implanted.It was mentioned the t4 screwdriver shaft was not holding the screws very well.The procedure was completed successfully with a surgical delay of 10 minutes.Patient outcome was unknown.This complaint involves five (5) devices.This report is for (1) 1.5 cortex screw slf-tpng t4 sd rec 11.This report is 2 of 2 (b)(4).

• Brand Name: 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 11
• 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: 11728673
• Report Number: 2939274-2021-02084
• Device Sequence Number: 19791419
• Product Code: HWC
• UDI-Device Identifier: 10886982055453
• UDI-Public: (01)10886982055453
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.214.111
• Device Catalogue Number: 02.214.111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 68