MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG HP REV TORQ LMT SCRWDRVR; KNEE INSTRUMENT : TORQUE DEVICES

Catalog Number 201103080

Device Problems Calibration Problem (2890); Device-Device Incompatibility (2919)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthese, or its employees that the report constitutes an admission that the product, depuy synthese, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the driver and driver handle are stuck together, no adverse events no delays.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary it was reported that the driver and driver handle are stuck together, no adverse events no delays.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found the sig hp rev torq lmt scrwdrvr assemble with the mating device attune rev systm hex attachmnt.Both devices cannot be disassemble a dimensional inspection was not performed due to post manufacturing damage.A functional test was performed attempting to disassembling the mating devices and it was not possible to pull off the instruments.Observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces such as was consistent with impacting the device off axis and possible before is fully connected.A functional test with a torque tester was not able to performed due to the mating device was not possible to disassemble the overall complaint was confirmed as the observed condition of the sig hp rev torq lmt scrwdrvr would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot
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> the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SIG HP REV TORQ LMT SCRWDRVR
• Type of Device: KNEE INSTRUMENT : TORQUE DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18691281
• MDR Text Key: 335944288
• Report Number: 1818910-2024-02975
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295436379
• UDI-Public: 10603295436379
• 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,Followup,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201103080
• Device Lot Number: KM867591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 04/05/2024
• Supplement Dates FDA Received: 02/29/2024; 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2018
• 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
• Patient Age: 63 YR
• Patient Sex: Male