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

Model Number 2506-20-102

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

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that upon inspection of instruments after case discovered that cemented tibial revision reamer was slightly bent and will no longer pass through bushing freely.There was no surgical delay.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was returned for analysis.Visual analysis revealed that the device has evidence of normal use and service.The device interaction (2+ devices)report allegations cannot be confirmed due to the functional test could not be performed as the mating device was not returned.Also, no evidence of malformed, warped, and/or distorted were found, therefore the report allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? drw# (b)(4) rev b current and manufactured.Dimensional inspection: drawing: drw# (b)(4), feature: male connector diameter , specification: 7.39 mm (+/- 0.08), measured dimension: 7.39 mm, result: conforming.Measurement device: caliper mitutoyo cd-6" asx id# (b)(4).Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: ATTUNE REV CEM TIB STEM REAMER
• 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 46580 ; 3035526892
• MDR Report Key: 16024837
• MDR Text Key: 306426561
• Report Number: 1818910-2022-25953
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2506-20-102
• Device Catalogue Number: 250620102
• Device Lot Number: NG103414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• 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: Male