MAUDE Adverse Event Report: DEPUY SPINE INC TORQUE WRENCH

Catalog Number 277040510

Device Problem Mechanical Problem (1384)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

It was reported that some instruments were observed to not be in great condition while going through/restocking the sets.There was no patient involvement/consequences.This report is for one (1) torque wrench.This is report 4 of 5 for 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a j&j sales representative.H3, h4, h6 the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the torque wrench, exhibits signs of normal use.A dimensional inspection for the torque wrench was not performed since it was not applicable to the complaint condition.A functional test was performed using torque meter ez-torq lll 150i torque, id# cd78632, adaptor vf1030000.Drawing no.(b)(4), rev.G (manufactured) was used as source of specification.Torque handle is required to deliver 72 -88 lb.In at intermediate setting.Actual measured values range from 101.08 - 106.13 lb.In.The complaint condition was replicated because the device don't passed the torque test.Refer to attachment (b)(4) lbin.For results.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications the overall complaint was confirmed as the observed condition of the torque wrench, p/n: 277040510, lot: km878154 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that 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.Drawing/specifications reviewed.Dwg no.(b)(4) rev.H current and manufactured.Dimensional inspection: n/a.H4, h6; part # 277040510.Lot # km878154.Supplier: (b)(4).Batch1: lot units were released on 15 july 2020 with no discrepancies.No non conformance were generated during production.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: TORQUE WRENCH
• Type of Device: WRENCH
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17807002
• MDR Text Key: 324124039
• Report Number: 1526439-2023-01801
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034196770
• UDI-Public: (01)10705034196770
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 277040510
• Device Lot Number: KM878154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• 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: CLIP-ON RED DEVICE DI IMPLANTS; CLIP-ON RED DEVICE DI IMPLANTS; CLIP-ON RED DEVICE DI IMPLANTS; CLIP-ON RED DEVICE DI IMPLANTS; FRENCH ROD BENDER; ROD CLAMP, RATCHETING,STRAIGHT; SINGLE INNIE INSERTER; X25 FINAL TIGHTENER; XPDM QUICK-CON DI POLY SCWDRVR; XPDM QUICK-CON DI POLY SCWDRVR; XPDM QUICK-CON SI POLY SCWDRVR