MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

Model Number 399.99

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information available for reporting.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the tip of the reduction forceps broke off during a patient procedure on (b)(6) 2018.This occurred during a forearm fracture repair procedure.As the surgeon was pressing the forceps to reduce the fracture, the tip of the forceps broke.The fragment was retrieved.There was a back-up instrument for surgeon to use to successfully complete the case.There was no surgical delay.No patient harm was reported.Patient outcome was reported fine.This is report 1 of 1 for (b)(4).

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: 399.99; synthes lot: t935872; release to warehouse date: may 29, 2009; manufacture site: tuttlingen; part expiration date: n/a; list of nonconformance¿s: n/a.A review of the device history records (dhr) showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.No nonconformance reports (ncrs) were generated during the production of this device.Complaint summary: it was reported that the tip of the reduction forceps broke off during a patient procedure, fragments were retrieved.Flow: broken device condition: the forceps (part 399.99, lot t935872, mfg may 29, 2009) was received at us cq broken.The forceps were originally returned to service and repair.The repair technician reported the right jaw of the forceps broke off.Tip broken is the reason for repair.The item is not repairable per the inspection sheet, thus it was forwarded to us cq.The right arm of the forceps was broken at the distal tip.The complaint condition was visually confirmed and consistent with the reported condition.Lot number review: dhr review showed no ncrs were generated during production.The material, and material properties of the returned part were determined to be conforming at the time of manufacture based on review of the dhr(s).Drawing review: the following drawing(s) was reviewed; reduction forceps with serrated jaw , reduction forceps with serrated jaw.Dimensional analysis could not be performed as relevant features are significantly deformed by post manufacturing damage.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed as the forceps were received broken.A device inspection, device history record review and drawing review were performed as part of this investigation.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the multiuse device (9+ years old) encountered unintended forces.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Reporter is a health professional.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-RATCHET 144MM
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7435743
• MDR Text Key: 106080144
• Report Number: 2939274-2018-51756
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982203175
• UDI-Public: (01)10886982203175
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 399.99
• Device Catalogue Number: 399.99
• Device Lot Number: T935872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1