MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATT THEM BAL DISTRACT HANDLE; SIZING/MEASURING INSTRUMENTS

Model Number	2545-06-009
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
End of afternoon, the surgeon had issue to distract the knee with the themis.The instrument was introduced in extension, the surgeon was supporting the back of the knee but when he was quizzing the handle to distract the spring was compressing (up to maximum) but the tenser was not applying any tension on the articulation (he was not moving); the tenser had space in the articulation, it was moving a bit but was not distracting.Out side the knee the tenser was distracting when squeezing the handle but it was a bit difficult to bring it back to 0 and when the sales rep was mounting it she filled difficult to put the femoral part in the tibial part.This problem happened already once a few week ago with the same problem.But they were not thinking of issue with the themis (see complaint (b)(4)).The sales rep come on (b)(6) 2021 to see what was happening.It was a right knee.No additional time of the surgery and no negative effect for the patient the surgeon used the spacer bock to check the spaces.The themis is on consignment, it will be sent back to (b)(6) for investigation.On (b)(6) 2021 the surgeon did a second knee with themis and it works well.
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.
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 examination and functional evaluation of the returned device revealed no visual or functional defects.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATT THEM BAL DISTRACT HANDLE
• Common Device Name: SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork IN ; EI
• 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: 12721583
• Report Number: 1818910-2021-24068
• Device Sequence Number: 3706139
• Product Code: HWT
• UDI-Device Identifier: 10603295497035
• UDI-Public: 10603295497035
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2021

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: 2545-06-009
• Device Catalogue Number: 254506009
• Device Lot Number: GB118546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 02/01/2022; 03/02/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 02/03/2022; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown