MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH TORQUE WRENCH

Model Number 277040510

Device Problem Mechanical Problem (1384)

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

Event Date 09/02/2021

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2021, a torque was not working.There was no patient delays or adverse effects.Handle is very old and needs to be replaced.The procedure was successfully completed.During manufacturer's investigation of the returned device it was identified the device failed torque test.This device condition was evaluated and determined as reportable on (b)(6) 2022.This report is for one (1) torque wrench this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the complaint device torque wrench (product code: 277040510, lot number: e1104) was returned to cq west chester for investigation.The torque wrench was severely scratched and the paint coat had been corroded off the item.Functional test: the item failed the torque test by testing out of the specified range.Dimensional inspection: complaint relevant dimension could not be measured as the internal components were inaccessible without the destruction of the device.Document/specification review: the date of manufacture for the device was not available, hence current revision of the drawing was reviewed.Complaint confirmed: yes, the complaint condition can be confirmed during physical device investigation.Conclusion: the torque failed the functional test by testing out of specification.A definitive assignable root cause of this could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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.Lot # provided is not a valid number, therefore, the dhr could not be completed.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): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13458157
• MDR Text Key: 288195936
• Report Number: 1526439-2022-00183
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034196770
• UDI-Public: (01)10705034196770
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 277040510
• Device Catalogue Number: 277040510
• Device Lot Number: E1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• 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