MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CONV SHIM SZ7 14MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500942

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned device confirms the reported event of trial damage.The observed cracking is initiating around the metal insert of the trial.A pra (b)(4) (preliminary risk assessment) meeting was held to discuss a product escalation out of australia concerning the attune shims.The team has determined that there is no additional patient risk associated with this issue.Although cracks are occurring, this failure mode does not lead to a patient harm of infection.The rate of infection for attune is within the state rate in the risk management report and is statistically similar to the rate of infection for the total knee class.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 performed investigation and pra (b)(4) determination of no additional patient risk, corrective action is not indicated.Continue to monitor via sep-419.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 instruments were broken.Didn't impact any case.

Manufacturer Narrative

(b)(4).Investigation summary examination of the returned device confirms the reported event of trial damage.The observed cracking is initiating around the metal insert of the trial.A pra(b)(4) (preliminary risk assessment) meeting was held to discuss a product escalation out of australia concerning the attune shims.The team has determined that there is no additional patient risk associated with this issue.Although cracks are occurring, this failure mode does not lead to a patient harm of infection.The rate of infection for attune is within the state rate in the risk management report and is statistically similar to the rate of infection for the total knee class.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 performed investigation and pra(b)(4) determination of no additional patient risk, corrective action is not indicated.Continue to monitor via (b)(4).If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CONV SHIM SZ7 14MM
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7673389
• MDR Text Key: 113527752
• Report Number: 1818910-2018-64105
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295135197
• UDI-Public: 10603295135197
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500942
• Device Lot Number: BFA0RL3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1