MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB CEM CONICAL RMR; ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS

Catalog Number 250620103

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

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 when reaming through the tibia prep tower, the tibia boss reamer bound up in the tower.It was noted after the case that the reamer had become deformed due to rifling and is no longer useable.

Event Description

A.Did the event occur during the surgery? yes,if yes, was there a surgical delay? 5 minute delay to separate the instruments from each other.What is the duration of the delay? 5 minutes b.Were there any pieces broken off from the instrument? no c.Did it break into 2 or more pieces? no there is no indication that the prolonging of the surgical procedure occurred at a critical procedure step where high risks to the patient may be present.There is no indication that the delay or the malfunction resulted in any impact to the expected surgical outcome, or caused any patient consequence or injury.

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.H10 additional narrative: added: b5, h6 impact code if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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.H10 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.Corrected: h3.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary according to the following information: "it was reported that when reaming through the tibia prep tower, the tibia boss reamer bound up in the tower.It was noted after the case that the reamer had become deformed due to rifling and is no longer useable.Please ship replacement to sales rep".The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of device returned revealed reamer blades of attune rev tib cem conical rmr deformed due to heavy use.Additionally, several scratches were observed on the medial portion of the shaft.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces such as off axis drilling under power and not properly align the reamer prior the insertion into the tower.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since its mating device was not returned for evaluation.Therefore, jammed allegation cannot be confirmed.The overall complaint was confirmed as the observed condition of the attune rev tib cem conical rmr would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is required.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.

• Brand Name: ATTUNE REV TIB CEM CONICAL RMR
• Type of Device: ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS
• 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: 18837006
• MDR Text Key: 336893331
• Report Number: 1818910-2024-05000
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295440567
• UDI-Public: 10603295440567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 250620103
• Device Lot Number: NG79900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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