MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE TIBIA DRILL; DRILLS

Catalog Number	254500125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
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.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.
Event or Problem Description
It was reported that the patient underwent a tka surgery performed with the device in question.During the previous day's explanation of the device, the fit between the tibial drill and the red ring was normal.During the instrument assembly before the surgery, the tibial drill bit was broken, and the red ring did not fit and came off.The breakage itself was thought to have occurred during cleaning.It did not enter the body.During the surgery, the surgeon managed to operate it well and completed the drilling.If it were to break during the operation, it would be dangerous because it is a small part.The surgery was completed successfully with no 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 that 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 that was not available for the initial report is obtained, a follow-up report 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.H11 additional narrative: added: d9.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 on (b)(6) 2025, the patient underwent a tka surgery performed with the device in question.During the previous day's explanation of the device, the fit between the tibial drill and the red ring was normal.During the instrument assembly before the surgery, the tibial drill bit was broken, and the red ring did not fit and came off.The breakage itself was probably during cleaning.It did not enter the body.During the surgery, the surgeon managed to operate it well and completed the drilling.If it were to break during the operation, it would be dangerous because it is a small part.No further information is available.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that one of the two ball plunger has fall apart from its original position and remains attached to the main device.However signs of breakage were not observed.Additionally the sample presents signs of multiple use for a long period of time.The observed condition of the device could be consistent exposure to unintended forces, such as applied excessive forces while assembling or disassembling from the mating device, heavy usage.However due to the low frequency of this occurrences and not suspecting any design issue, a definitive root cause cannot be established.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune tibia drill would have contributed to the complained 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 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.H11 additional narrative: corrected: h3.

• Brand Name: ATTUNE TIBIA DRILL
• Common Device Name: DRILLS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22335302
• Report Number: 1818910-2025-10619
• Device Sequence Number: 18375314
• Product Code: HWE
• UDI-Device Identifier: 10603295427568
• UDI-Public: (01)10603295427568(10)NG107743
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,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: 254500125
• Device Lot Number: NG107743
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 07/10/2025; 07/29/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/01/2025; 07/11/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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 Sex: Unknown