MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC IM REDUCTION TOOL/CURVED WITH QUICK COUPLING; MISC ORTHO SURGICAL INSTR

Model Number	03.010.495
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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) 2021 during an unknown procedure, one (1) slide/fixed hammer and one (1) im reduction tool/curved with quick coupling were broken, one (1)2.7mm va-lcking anterolateral calcaneal pl was stripped and one (1) 5.0mm flexible shaft was bent.There were no fragments generated.There was an unspecified amount of surgical delay.The procedure was successfully completed.There was no patient consequence.This report is for one (1) im reduction tool/curved with quick coupling.This is report 2 of 4 for (b)(4).
Event or Problem Description
This is report 3 of 4 for (b)(4).

• Brand Name: IM REDUCTION TOOL/CURVED WITH QUICK COUPLING
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11329973
• Report Number: 2939274-2021-00857
• Device Sequence Number: 934239
• Product Code: LXH
• UDI-Device Identifier: 10886982069122
• UDI-Public: 10886982069122
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 03.010.495
• Device Catalogue Number: 03.010.495
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: 2.7MM VA-LCKING ANTEROLATERAL CALCANEAL PL SHORT; 5.0MM FLEXIBLE SHAFT 620MM; SLIDE/FIXED HAMMER 700 GRAMS