MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT CUTTER; CUTTER,WIRE

Model Number 388.72

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is jnj representative.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 Description

It was reported that on an unknown date, during routine inspection of sets, one (1) bolt cutter cutting edge was chipped, two (2) depth gauge outer sleeve falls off due to missing bearing, one (1) depth gauge has a broken tip, one (1) guide sleeve has a broken/bent tip, one (1) cannulated stardrive twisted tip, two (2) screwdrivers has a broken tip.One (1) driving cap has a broken tip, one (1) extraction instrument was stripped insertion threads, one (1) handle with quick coupling has a broken handle, one (1) handle sleeve with unknown allegation: one (1) torque limiter and one (1) tension holder driver won't lock, and one (1) drill sleeve has an unknown allegation.There was no patient involvement.This complaint involves fifteen (15) devices.This report is for (1) bolt cutter this is report 1 of 8 (b)(4) related product complaint: (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.H3, h6: part: 388.72.Lot: t165145.Manufacturing site: tuttlingen.Release to warehouse date: may 15, 2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Service and repair evaluation: the customer reported the bolt cutter cutting edge was chipped.The repair technician reported that the cutting jaws were damaged, and pieces were missing.Cutting jaws broken is the reason for repair.The cause of the issue is not determined.The item was repaired per the inspection sheet, passed synthes final inspection, and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer.No design or manufacturing issues were identified therefore, it has been determined that no corrective and/or preventative action is proposed.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: BOLT CUTTER
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10497249
• MDR Text Key: 206710139
• Report Number: 2939274-2020-03984
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10705034773759
• UDI-Public: (01)10705034773759
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 388.72
• Device Catalogue Number: 388.72
• Device Lot Number: 165145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLADE/SCREW GUIDE SLEEVE; CANNULATED CRUCIFORM SCREWDRIVER; CANNULATED STARDRIVE SCREWDRIVER/T15; CRUCIFORM SCREWDRIVER; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; DRIVING CAP/THREADED; NAIL EXTRACTOR