MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATUNE REV ASMBLY OFST STABLIZR; KNEE INSTRUMENTS: ALIGNMENT DEVICE

Catalog Number	254600422
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the attune offset stabilizer was broken again during a procedure.The instrument was torqued by hand, causing the instrument to cross thread.This instrument was needed during the operation and they had to try and find alternatives during the operation as a result of this breakage.The operation was delayed as a result of this, but aside from that no patient outcomes were affected.
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.
Event or Problem Description
Additional information received states that the surgical delay was between one and two hours as the procedural plan had to be altered due to being unable to use instruments as originally planned.The instrument didn¿t break into two or more pieces.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received "the attune offset stabilizer was broken again.During a procedure, the instrument was torqued by hand, causing the instrument to cross thread.This instrument was needed during the operation and they had to try and find alternatives during the operation as a result of this breakage.The operation was delayed as a result of this, but aside from that no patient outcomes were affected.The product was not returned to medtech orthopedics; however, photos were provided for review.The device associated with this report was not returned to medtech orthopedics for evaluation.The photographs attached were reviewed, however in the images provided no observations pertaining to the nature of the reported event could be identified as only half the device is visible in photo.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs attached don¿t have any evidence to draw a conclusion about the reported event.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 complaint condition.As part of medtech orthopedics 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because lot code provided is not a valid finished goods lot.

• Brand Name: ATUNE REV ASMBLY OFST STABLIZR
• Common Device Name: KNEE INSTRUMENTS: ALIGNMENT DEVICE
• 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 ; 3035526892
• MDR Report Key: 21048046
• Report Number: 1818910-2024-26211
• Device Sequence Number: 14272173
• Product Code: LXH
• UDI-Device Identifier: 10603295440352
• UDI-Public: (01)10603295440352
• 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,Followup

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: 254600422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 02/13/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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