MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE SHIM SZ9 5MM; KNEE INSTRUMENT/TRIAL

Catalog Number 254500691

Device Problems Disassembly (1168); Component Missing (2306)

Patient Problem No Information (3190)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Shim has returned without steel insert.This case has been reported by the loan kit technician during loan kit inspection.

Manufacturer Narrative

The device associated with this report was not returned.Follow up communication for product return was unsuccessful.A complaint database search on the provided product code family showed similar reports for damage/cracking.Previous reports found user technique, misuse, or the use of a contraindicated cleaning chemical, as suspected root causes.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Based on the inability to identify root cause, the need for corrective action was not indicated.Continue to monitor via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

This investigation has been reopened because the product has been received.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

Examination of the returned device confirms the reported event of a missing metal insert.A complaint database search on the provided product code family showed similar reports for damage/cracking.Previous reports found user technique, misuse, or the use of a contraindicated cleaning chemical, as suspected root causes.Although a definitive root cause is not known, a combination user technique, improper technique or misuse, and the use of contraindicated chemicals (non-compliant to cleaning guidelines), may lead to weakening of the material, as seen in the returned device.Based on the inability to determine a specific root cause, a need for corrective action is not indicated.Continue to monitor via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE SHIM SZ9 5MM
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5284826
• MDR Text Key: 33101497
• Report Number: 1818910-2015-37119
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2016

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: 254500691
• Device Lot Number: BFA0MQG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2015; 01/11/2016; 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• 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