MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION FORCEPS; INSTRUMENT, COMPRESSION

Model Number	03.211.400
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: the compression forceps (p/n: 03.211.400, lot #:t949320) was received at us cq.The device was observed to have some wear on the teeth of the ratchet mechanism.There was also a chip of material missing from the small flap, component se_091691.No other device defects were noted.Functional test: the small flap, component, was put into the locking ratchet position.As the forceps were opened and closed throughout their range of motion, the small flap failed to engage with the ratchet teeth on the small ratcheting rail, component.Therefore, the device failed the functional test.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage and device geometry.Document/specification review: the relevant revisions of the product drawings were reviewed.No design issues or discrepancies were identified.Conclusion: the complaint condition is confirmed for the received device as the small flap component has a chip of material broken off, which prevents the device from functioning properly.A definitive assignable root cause cannot be determined from the provided information.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.A device history record (dhr) review was conducted: part number: 03.211.400.Lot number: t949320.Manufacturing site: (b)(4).Release to warehouse date: 15-jul-2010.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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 a procedure the compression forceps ratchet mechanism did not function correctly.The surgeon improvised and made it work.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.During manufacturer's investigation it was identified that device has some wear on the teeth of the ratchet mechanism.There was also a chip of material missing from the small flap.This report is for (1) compression forceps.This is report 1 of 1 for complaint (b)(4).

• Brand Name: COMPRESSION FORCEPS
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12701147
• Report Number: 2939274-2021-06319
• Device Sequence Number: 1558717
• Product Code: HWN
• UDI-Device Identifier: 10886982076267
• UDI-Public: (01)10886982076267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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: 03.211.400
• Device Catalogue Number: 03.211.400
• Device Lot Number: T949320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 100