MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WIRE CUTTER 220MM; CUTTER, WIRE

Model Number 391.93

Device Problems Corroded (1131); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device deemed reportable at conclusion of investigation on 20apr2022 reporter is a j&j employee.Investigation summary: service and repair evaluation: the customer reported that while looking through the back up items it was discovered that wire cutter was rusted.It was unknown where the issue was discovered.The repair technician reported that the device is rusted, tip is broken.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is damaged component.The item will be forwarded to customer quality.The evaluation was confirmed.Device history: the lot number a7ca017 is not correct, in the lot numbers only two-digit numbers were assigned.The correct lot number could be a7ca17, therefore the dhr review was performed for this lot: part number: 391.93, lot number: a7ca17, manufacturing site: (b)(4).Release to warehouse date: week 17, 1993.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over (b)(6)).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 inspection of the back up devices it was discovered that the gold peg of one (1) recon locking aiming arm for lfn nails-ex has snapped off, the threads of one (1) extraction screw for ti femoral & tibial nails and one (1) extraction screw/m8 for suprapatellar are stripped, and one (1) depth gauge for 2.0/2.4 and 2.7 screws was stuck in place.There was no patient involvement.This is report 5 of 5 for complaint (b)(4).This complaint is for a wire cutter.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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

This is report 5 of 6 for pc (b)(4).

• Brand Name: WIRE CUTTER 220MM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14251470
• MDR Text Key: 290461515
• Report Number: 2939274-2022-01550
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982198440
• UDI-Public: (01)10886982198440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 391.93
• Device Catalogue Number: 391.93
• Device Lot Number: A7CA17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; EXTRACTION SCR FOR TI FEM & TIB NAIL; EXTRACTION SCREW/M8 FOR SUPRAPATELLAR; REAMING ROD PUSH ROD WITH BALL HANDLE; RECON LCKNG AIMING ARM FOR LFN NAILS-EX; SMALL UNIVERSAL CHUCK WITH T-HANDLE