MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING DEVICE FOR SCREW ONLY AIMING ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.037.140
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2021, the screw inserter was deformed.Upon insertion of the lag screw using the screw inserter the insertion t handle device became unattached from the lag screw and prevented further insertion.The t handle inserter and coupling screw were inspected and seemed to be disfigured.It is unknown if there was a surgical delay.The procedure outcome was unknown.No patient consequences.Concomitant device reported: helical blade/screw coupling screw (part: 03.037.026; lot:3l89171; quantity: 1).Screw inserter (part number 03.037.025, lot unknown, quantity 1).Screws: lag (part number unknown, lot unknown, quantity 1).This report involves one (1) locking device for screw only aiming arm.This is report 2 of 4 for (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.H3, h4, h6: part 03.037.140, lot 9708261: manufacturing site: bettlach.Release to warehouse date: december 03, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: visual inspection of the complaint device showed two of the flanges had broken off.A dimensional inspection was not performed due to post-manufacturing damage.The current and manufactured to drawings were reviewed; no design issues or discrepancies were identified.This complaint is confirmed as two of the flanges have broken off, preventing the device from performing its function.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 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: LOCKING DEVICE FOR SCREW ONLY AIMING ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11337326
• Report Number: 2939274-2021-00894
• Device Sequence Number: 883951
• Product Code: LXH
• UDI-Device Identifier: 10886982070593
• UDI-Public: (01)10886982070593
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 01/22/2021

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: 03.037.140
• Device Catalogue Number: 03.037.140
• Device Lot Number: 9708261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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: HELICAL BLADE/SCREW COUPLING SCREW; SCREW INSERTER; UNK - SCREWS: LAG; HELICAL BLADE/SCREW COUPLING SCREW.; SCREW INSERTER.; UNK - SCREWS: LAG.
• Patient Age: 54 MO