MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS POINTS RATCHET 174

Model Number	399.94
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
Additional narrative: initial reporter is a j&j employee.Part number: 399.94, lot number: t197200, manufacturing site: (b)(4), release to warehouse date: april 24, 2020.A review of the device history records was performed for the finished device lot number, and no non-conformance were identified.The customer reported that the reduction forceps points rachet were found damaged after use in surgery.The repair technician reported loose screw, tag weld on screw broken.Loose component is the reason for repair.The cause of the issue is unknown.The item was repaired per the inspection sheet, passed synthes final inspection and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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 an unknown date, the two (2) reduction forcep points rachet, protection sleeve, trocar, sharp hook, insertion guide, two (2) t-handle with quick coupling, screwdriver shaft, driving cap and radiolucent insertion handle were found damaged after use in surgery.There was no patient consequence reported.This report involves one (1) reduction forceps with points ratchet 174mm.This is report 4 of 8 for (b)(4).

• Brand Name: REDUCTION FORCEPS POINTS RATCHET 174
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14345588
• Report Number: 2939274-2022-01694
• Device Sequence Number: 4698007
• Product Code: HTD
• UDI-Device Identifier: 10886982203137
• UDI-Public: (01)10886982203137
• 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

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: 399.94
• Device Catalogue Number: 399.94
• Device Lot Number: T197200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVING CAP F/INSERTION HANDLE; DRIVING CAP/THREADED; INSERTION GUIDE; PROTECT SLEEVE 12/8 L188; RADIOLUCENT INSERTION HANDLE FRN; REDUCTION FORCEPS POINTS RATCHET 13; SDDRIVE SCREWDRIVER SHAFT QC/T15; SHARP HOOK; T-HANDLE WITH QUICK COUPLING; T-HANDLE WITH QUICK COUPLING; TROCAR Ø4.2 F/03.010.065
• Patient Sex: Unknown