MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOOK/SCREW HOLDER WITH 4.0MM HEX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	388.612
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that, rod holder was not working properly.The screw extensions tips were bent and aren't screwing in properly.I haven't inspected it myself to determine the actual issue but will pick it up and send it in shortly.This report is for one (1) hook/screw holder with 4.0mm hex.This is report 1 of 2 for complaint (b)(4).

• Brand Name: HOOK/SCREW HOLDER WITH 4.0MM HEX
• 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: 12086723
• Report Number: 2939274-2021-03302
• Device Sequence Number: 14368156
• Product Code: LXH
• UDI-Device Identifier: 07611819718432
• UDI-Public: (01)07611819718432
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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 Catalogue Number: 388.612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/29/2021
• 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: HOLD-FORCEPS F/R Ø6; USS-HOOK+SCRHOLDER W/HEX-SOCKET Ø4