MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE LTL CEM TIBIAL DRILL; DRILLS

Catalog Number	254500165
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional 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 synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 or Problem Description
The ball bearing of the tibial drill seem to have dropped into the drill itself, therefore it does not grip the drill stop properly.It caused less than 1 minute delay to surgery and no impact to the patient.
Additional Manufacturer Narrative
Product complaint (b)(4).The impacted product coding has been modified from broken to jammed/seized, as the ball bearing identified in the complaint has been found to be jammed inside the barrel of the drill (not providing any spring tension to the instrument), rather than having broken loose from the drill instrument.The current coding is not reportable.

• Brand Name: ATTUNE LTL CEM TIBIAL DRILL
• Common Device Name: DRILLS
• 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: 19562584
• Report Number: 1818910-2024-13205
• Device Sequence Number: 15324355
• Product Code: HTW
• UDI-Device Identifier: 10603295445647
• UDI-Public: (01)10603295445647
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 06/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 254500165
• Device Lot Number: NG107827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2022
• 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