MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RATCHETING HANDLE WITH QUICK COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.100.032
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.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 the surgeon was attempting to use the ratcheting handle with quick coupling to remove and replace the unknown compression screw while the ratchet handle would no longer ratchet.Surgeon requested a second pelvic instrument tray for the second ratchet handle with quick coupling which would also no longer ratchet.Surgeon then proceeded to use a small handle quick coupling screwdriver with the power shaft to remove and insert screws.Procedure was successfully completed with five(5) minutes surgical delay.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) ratcheting handle with quick coupling.This is report 2 of 2 for complaint (b)(4).

• Brand Name: RATCHETING HANDLE WITH QUICK COUPLING
• 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: 12112179
• Report Number: 2939274-2021-03393
• Device Sequence Number: 17278474
• Product Code: LXH
• UDI-Device Identifier: 10886982070814
• UDI-Public: (01)10886982070814
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 06/11/2021

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: 03.100.032
• Device Catalogue Number: 03.100.032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1