MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SHIM SZ9 8MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500693
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Root cause and corrective action are documented in the capa system.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Investigation of the returned device confirms the complaint; the shim has broken.It should be noted that all pieces have been returned.A preliminary risk assessment (b)(4) was initiated in march 2015 to investigate if the risk of infection was increased if a shim with a crack was used during surgery.Microbiological trials conducted as part of the pra found that the risk of infection from a crack (when used across surgeries) is remote.The attune shim returned is of a three piece construction, a plastic section with two steel bushes press fit into the radel base.This is now known to leave residual stresses in the plastic portion of the component, leading to cracks in some cases.A design change under co (b)(4) was completed in (b)(6) 2016 which removed the steel bushes from the design and making it a one piece construction.As this device was of the old design and there were no reported harms no further work is required.Continue to monitor via sep-419.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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
It was reported that both instruments are cracked.They were not used in the case.

• Brand Name: ATTUNE SHIM SZ9 8MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8887899
• Report Number: 1818910-2019-100895
• Device Sequence Number: 2883494
• Product Code: HWT
• UDI-Device Identifier: 10603295133650
• UDI-Public: 10603295133650
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 254500693
• Device Lot Number: BFA0N8R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1