MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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	02/12/2024
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.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 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.
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.
Event or Problem 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.
Additional 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 - (b)(6)).Visual examination found no damage on attune distal fem cut block.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 fem cut block 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: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ATTUNE DISTAL FEM CUT BLOCK
• Common Device Name: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 18756634
• Report Number: 1818910-2024-03916
• Device Sequence Number: 6601708
• Product Code: HTZ
• UDI-Device Identifier: 10603295423737
• UDI-Public: 10603295423737
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 254400522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 02/26/2024; 03/06/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 02/27/2024; 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female