MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 CAS LIGAMENT TENSOR SIZE 4-XF; SURGICAL ACCESSORIES : ALIGNMENT DEVICES

Model Number	1299-01-081
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Two each size 4 ligament tensors were found defective upon receipt.The springs are bent and catching on the tray.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.The analysis of the returned parts confirmed the reported issue.Both returned instruments had deformed springs, most prominently the left spring (when viewed from the posterior side).The status of these springs appeared to impact the orientation of the top plate relative to the bottom plate.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a manufacturing investigation was performed.There were (b)(4) total parts in the lot and inspection revealed no defects or anomalies.Based on the manufacturing rerecords provided, all the parts ((b)(4) total) passed visual and functional checks by the manufacturer.Device history review: a manufacturing investigation was performed.There were (b)(4) total parts in the lot and inspection revealed no defects or anomalies.Based on the manufacturing rerecords provided, all the parts ((b)(4) total) passed visual and functional checks.

• Brand Name: CAS LIGAMENT TENSOR SIZE 4-XF
• Common Device Name: 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13019438
• Report Number: 1818910-2021-28300
• Device Sequence Number: 4963479
• Product Code: HWT
• UDI-Device Identifier: 10603295027089
• UDI-Public: 10603295027089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1299-01-081
• Device Catalogue Number: 129901081
• Device Lot Number: AB5051588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 12/29/2021; 05/26/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/05/2022; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown