MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET

Model Number	399.124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is synthes sales consultant.A device history record (dhr) review was conducted: part #: 399.124.Lot #: 5029.Manufacturing site: bettlach.Release to warehouse date: 07.Oct.2002.Dhr not available as device is older than 16 years.At this time the manufacturing documents for instruments had to be stored for 10 years.A product investigation was conducted.Visual inspection: the reduction forceps w/serrated jaw-large handle-soft ratchet (part # 399.124, lot # 5029) was received at us cq.One of the serrated jaws were clearly broken at its distal tip.No fragments were returned.The device has light surface scratches along its body and some discoloration/rust on one of its handles.The received condition of the device is consistent with the complaint condition thus the complaint is confirmed.Dimensional inspection: a dimensional inspection was not performed due to a lack of tolerance dimensions at the fracture site.Conclusion:the complaint was confirmed for the reduction forceps w/serrated jaw-large handle-soft ratchet (part # 399.124, lot # 5029).The device was returned broken, one of the serrated jaws were clearly broken at its distal tip with no fragments returned.There were light scratches along its body and some discoloration/rust on one of its handle.These cosmetic issues are consistent with normal wear.Although no definite root cause could be determined for the broken condition, it is possible that the device experienced unintended forces during use.No design issues were observed during the document/specification review.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 (b)(6) 2019, the reduction forceps with serrated jaw large handle soft ratchet tip of the forceps actually broke off.It was mentioned that they had to take additional images during the case to find the piece that broke off and it took around ten (10) minutes to remove it.Used a different forceps to reduce the femur.Procedure completed fine.Patient outcome is unknown.This report is for one (1) reduction forceps w/serrated jaw-large handle-soft ratchet this is report 1 of 1 for complaint (b)(4).

• Brand Name: REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8865779
• Report Number: 2939274-2019-59542
• Device Sequence Number: 2877124
• Product Code: HTD
• UDI-Device Identifier: 10886982202390
• UDI-Public: (01)10886982202390
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

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: 399.124
• Device Catalogue Number: 399.124
• Device Lot Number: 5029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1