MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK

Model Number	399.051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.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 on an unknown date, during open reduction internal fixation (orif) of distal humerus, the tip of the reduction forcep with separated jaw broke off while trying to hold a reduction.Fragments were generated and were removed easily without additional intervention.Another clamp was used to finish the case successfully.The procedure was successfully completed with five minutes surgical delay.Patient status is unknown.Concomitant medical products reported: unknown reduction (part# unknown, lot# unknown, quantity# unknown).This complaint involves one (1) device.This report is 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.Visual inspection performed at customer quality observed that the tip of the jaw of the reduction forceps with serrated jaw 240mm-speed lock was broken.Broken fragments were not 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 of the reduction forceps with serrated jaw 240mm-speed lock (399.051) cannot be performed due to the post manufacturing damage of the tip of the jaw.Relevant drawings for the returned device, forceps were reviewed during investigation, and no design issues were found which can contribute to this complaint condition.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Traceability to the raw material certificate could not be established during this review.Investigation conclusion: a visual inspection and document/specification review were performed as part of this investigation.The complaint device was observed to be broken at the tip of the jaw of the forceps, thus confirming the complaint.While a definitive root cause could not be identified that contributed to the 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 history lot: part number: 399.051.Lot number: t934780.Manufacturing site: tuttlingen.Release to warehouse date: 28-may-2009.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Traceabilty to the raw material certificate could not be established during this review.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 WITH SERRATED JAW 240MM-SPEED LOCK
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8488862
• Report Number: 2939274-2019-57329
• Device Sequence Number: 11462696
• Product Code: HTD
• UDI-Device Identifier: 10886982202253
• UDI-Public: (01)10886982202253
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: 399.051
• Device Catalogue Number: 399.051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/06/2019
• Patient Sequence Number: 1
• Patient Age: 63 YR