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 1 of 2 (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary - background: it was reported that on march 30, 2021, patient underwent a hand surgery procedure.Initial injury was sustained from a gun shot 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.Visual inspection: the 1.5 cortex screw slf-tpng t4 sd rec 11 (p/n: 02.214.111, lot number: unk) was received at us cq.Visual inspection of the complaint device showed the head was stripped and the shaft was bent.Dimensional inspection: drawing: 02_214_104 rev b.Specified dimensions: measured dimensions: thread md = 1.46mm, conforming.Device used - caliper ca215p.Document/specification review: 02_214_104 rev b (current) was reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the head was stripped and the shaft was bent.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - the lot number is unknown, therefore no mre can be performed.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.

• 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: 11728622
• Report Number: 2939274-2021-02083
• Device Sequence Number: 14411124
• 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,Followup,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021; 05/27/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/26/2021; 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 11; 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 11; 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 11; SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC
• Patient Age: 25 YR
• Patient Weight: 68