MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 CAS LIGAMENT TENSOR SIZE 2-XF; SURGICAL ACCESSORIES : ALIGNMENT DEVICES

Model Number 1299-01-080

Device Problem Mechanical Jam (2983)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 the velys department received a call stating that the tensor had an issue and that it was not closing properly during an installation.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: CAS LIGAMENT TENSOR SIZE 2-XF
• Type of Device: SURGICAL ACCESSORIES : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14141089
• MDR Text Key: 289496279
• Report Number: 1818910-2022-06957
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295027072
• UDI-Public: 10603295027072
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/19/2022

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 Model Number: 1299-01-080
• Device Catalogue Number: 129901080
• Device Lot Number: AB5091100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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