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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 during inspection at the ortho station on an unknown date, it was noticed that the reduction forceps with serrated jaw was broken.The jaw portion was broken off, making it unusable.There was no patient involvement.This report is for a reduction forceps w/serrated jaw.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part 399.124, lot 5801884: manufacturing site: salzburg.Release to warehouse date: september 29, 2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The material was reviewed, and the hardness value was confirmed to meet the specification with no non-conformance noted.A product investigation was completed: visual inspection performed observed that the jaw of the reduction forceps was broken; the broken part was returned.The fracture surface appears homogeneous with no voids or dark spots.No sign of damage was observed on the remaining portions of the device except slightly worn surfaces which would not impact the device functionality.Dimensional inspection could not be performed due to the post manufacturing damage of the jaw.The relevant drawings were reviewed; no design issues were found which can contribute to this complaint condition.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The material was reviewed, and the hardness value was confirmed to meet the specification with no non-conformance noted.A visual inspection and document/specification review were performed as part of this investigation.The complaint device was observed to be broken at the jaw of the forceps, thus confirming the complaint.While a definitive root cause could not be identified that contributed to the complaint condition.It is possible that some unintended forces might have contributed to the reported complaint condition.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.

• 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: 8629135
• Report Number: 2939274-2019-58187
• Device Sequence Number: 2260320
• Product Code: HTD
• UDI-Device Identifier: 10886982202390
• UDI-Public: (01)10886982202390
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2019

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: 5801884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/06/2019; 06/17/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/17/2019; 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1