MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DISTAL FEM CUT BLOCK; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number	254400522
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when inserting pin into block, pin would not go through the pin hole and resulted in the pin breaking and a piece of the pin got stuck in the pin hole.Requiring replacement of the block.There was no surgical delays.Nothing was left in patient.
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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received states that there was no consequences to the patient and no 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.Corrected: h6 (health effect - impact code and health effect - clinical code) 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 when inserting pin into block, pin would not go though pin hole and resulted in the pin breaking and a piece of the pin got stuck in the pin hole.Requiring replacement of the block.There was no surgical delays.Nothing left in patient.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the attune distal fem cut block has a broken unknown fixation pin head stuck inside in one of the holes and cannot be removed, confirming the reported jammed condition.Broken fragments were not returned for evaluation.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like off axis insertion of the mating fixation pins and or the reuse of single use fixation pins.A functional test was performed and was able to replicate the reported jammed condition due to the devices were not able to disengage after multiple attempts with excessive forces applied.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 distal fem cut block 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.

• Brand Name: ATTUNE DISTAL FEM CUT BLOCK
• Common Device Name: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• 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: 20613758
• Report Number: 1818910-2024-23095
• Device Sequence Number: 8821098
• Product Code: HTZ
• UDI-Device Identifier: 10603295423737
• UDI-Public: (01)10603295423737(10)AB5022427
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 254400522
• Device Lot Number: AB5022427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/11/2024; 12/23/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/14/2024; 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 70 KG