MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE THEMIS STYLUS CYLINDER; KNEE INSTRUMENT: FEM BALANCED SIZER

Catalog Number	254506010
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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.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.
Event or Problem Description
It was reported that the fem sizer cylinder will not go down the cr right femoral sizer.
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 = > it was reported that the fem sizer cylinder will not go down the cr right femoral sizer.No obvious reason.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the attune themis stylus cylinder shows signs of scratches around the device.The scratches on the device may be due to multiple causes like an off axis assemble angle before the cylinder is align correctly to the sizer, prying motion while the attempts at assembly and disassembly from the sizer, tools and hard edges coming in contact with the device, however a definitive root cause cannot be determined due to the low incidence of this issue.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed with the alleged mating sizer and the cylinder was able to go all the way down by applying more pressure to it than what it is intended, since the device show signs of difficulty to assemble due to the scratches of the cylinder the assembly issues can be confirmed.The overall complaint was confirmed as the observed condition of the attune themis stylus cylinder would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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.Corrected: h3.

• Brand Name: ATTUNE THEMIS STYLUS CYLINDER
• Common Device Name: KNEE INSTRUMENT: FEM BALANCED SIZER
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20832545
• Report Number: 1818910-2024-24735
• Device Sequence Number: 4159536
• Product Code: HWT
• UDI-Device Identifier: 10603295514381
• UDI-Public: (01)10603295514381(10)GB125581
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• 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: 254506010
• Device Lot Number: GB125581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 12/26/2024; 01/13/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/27/2024; 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female