MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE REV SYSTM HEX ATTACHMNT; DRILL/DRIVER SHAFTS

Catalog Number	254600415
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
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 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 or Problem Description
It was reported that the screw driver and handle would not separate after case.Unknown surgical delay.
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.
Event or Problem Description
Additional information received: a.Was there any surgical delay related to the event? this was found "after the case".There were no details about the operative portion of the procedure because the screwdriver performed normally during that time.It was only after that there was an issue.B.Was there any patient consequence related to the event? no.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that the screw driver and handle would not separate after case.Unknown surgical delay.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that attune rev systm hex attachmnt was assembled with its mating device.Functional testing of the returned devices confirmed the reported inability to disassemble, multiple attempts were made to free up the adaptor component without success.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed condition of the returned devices may have been caused by some kind debris between the crevices of the locking feature and cause the device to stick or due the two devices being forced together when burrs were present.The overall complaint was confirmed as the observed condition of the sattune rev systm hex attachmnt would contribute to the complained device issue.Based on the investigation findings, 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 : 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.
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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE REV SYSTM HEX ATTACHMNT
• Common Device Name: DRILL/DRIVER SHAFTS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 18501665
• Report Number: 1818910-2024-00921
• Device Sequence Number: 18095672
• Product Code: HWR
• UDI-Device Identifier: 10603295451280
• UDI-Public: 10603295451280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 254600415
• Device Lot Number: PU114911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: Not provided; 02/06/2024; 02/29/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 01/19/2024; 02/08/2024; 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2017
• 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 Age: 64 YR
• Patient Sex: Male