MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ5 16MM; TIBIAL TRIALS

Catalog Number	254500931
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source is foreign.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Shim has cracked around the metal insert area.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # pc-(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 will be filed as appropriate.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened. .

• Brand Name: ATTUNE CONV SHIM SZ5 16MM
• Common Device Name: TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7502387
• Report Number: 1818910-2018-59293
• Device Sequence Number: 1512186
• Product Code: HWT
• UDI-Device Identifier: 10603295135081
• UDI-Public: 10603295135081
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/16/2018

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: 254500931
• Device Lot Number: BFA13A6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018; 05/10/2018; 05/11/2018; 05/11/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 05/10/2018; 05/11/2018; 05/16/2018; 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1