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

Model Number	399.94
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part: 399.94, lot: t197196, manufacturing site: (b)(4), release to warehouse date: february 13, 2020.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the reduction forceps points ratchet 174 was returned and received at us customer quality (cq).Upon visual inspection, weld was observed to be broken.Scratches were observed on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: during the functional test at service and repair, the screw weld has separated causing loosening of forceps.Service and repair evaluation: the customer reported the reduction forceps points ratchet is loose.The repair technician reported the screw weld has separated causing loosening of forceps.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Reduction forceps with points ratchet.Investigation conclusion: the complaint condition is confirmed for the reduction forceps points ratchet 174.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.
Event or Problem Description
It was reported that on an unknown date, the reduction forceps points ratchet was loose.There was no patient involvement.Upon manufacturer receipt and investigation, it was determined that the device was broken.This report is for a reduction forceps with points ratchet 174mm.This is report 1 of 1 for (b)(4).

• Brand Name: REDUCTION FORCEPS WITH POINTS RATCHET 174MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12121054
• Report Number: 2939274-2021-03410
• Device Sequence Number: 11657002
• 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
• Report Date (Section B): 05/10/2021

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: 399.94
• Device Catalogue Number: 399.94
• Device Lot Number: T197196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1