MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DISTAL FEMORAL JIG; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number 254400520

Device Problem Device-Device Incompatibility (2919)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  malfunction  

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.

Event Description

It was reported that the distal femoral cut guide, consisting of three pieces, is fixed in the bone, but at the time of removing it from jamming and found it difficult if release, once it was achieved it was removed.It was reassembled and fixed again and this time it was easier to release.Surgery was extended for a couple of additional minutes by repeating steps.The surgery was completed without more issues.Also, reported that the distal cut guide, the armed guide and the piece that points to the black arrow is the one that stuck and could not be released.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - according to the information received: it passes distal femoral cut guide, consisting of three pieces, is fixed in the bone, but at the time of removing it from jamming and fu difficult if release, once it was achieved it was removed all the gia was reassembled and fixed again and this time it was easier to release.I do not generate more discomfort except for a couple of additional minutes by repeating steps, continuous surgery without more news, sending format for a review of the piece i consider it is not necessary to remove it from the equipment.Below in the first photo appear the pieces that make up the distal cut guide, the second photo the armed guide and the piece that points to the black arrow is the one that stuck and could not be released.The product was not returned to depuy synthes, however photos were provided for review.See attachment (source file - reporte de novedad fundacion santa fe 463178).Visual examination found no damage on attune distal femoral jig.In addition, with evidence provided there is no certainty that jammed condition is present on device, therefore we cannot confirm the allegation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the attune distal femoral jig would not 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 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.

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 Description

Additional event information received: did the event occur during the surgery? if so, was there a surgical delay? what is the duration of the delay? yes, it was during the surgery, it caused a delay of about 8 minutes.Check if there was any adverse event or damage to the patient involved.There was no adverse event or harm to the patient.

• Brand Name: ATTUNE DISTAL FEMORAL JIG
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; 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: 18756633
• MDR Text Key: 335968994
• Report Number: 1818910-2024-03917
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295434030
• UDI-Public: 10603295434030
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 254400520
• Device Lot Number: AB5402385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/26/2024; 03/06/2024
• Supplement Dates FDA Received: 02/27/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female