MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SHIM SZ9 7MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-745
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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
Broken attune shims reported by (b)(6) staff.Did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? unknown, patient status/ outcome / consequences unknown, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study? unknown, (b)(4).Device property of: none, device in possession of none, b)(4).Device property of: none, device in possession of: none, b)(4).Device property of: none, device in possession of: none, (b)(4) device property of: none, device in possession of: none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint # : (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.  1818910-2020-09833 is being retracted since event was redetermined as not reportable.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
Additional information received confirmed that the devices did not break.Only a small crack was found on each devices.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The device was found to be cracked.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint sample consisted of (1) 254500745 attune shim sz9 7mm.Examination of the returned device confirmed the reported event.The device was found to be cracked.Small fissure cracks initiating around the metal insert of the trial were observed.A preliminary risk assessment (103121982) 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: two steel bushings press fit into a plastic 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 103137546 was completed in jan 2016 which removed the steel bushings from the design, 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 considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE SHIM SZ9 7MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9909182
• Report Number: 1818910-2020-09833
• Device Sequence Number: 14156858
• Product Code: HWT
• UDI-Device Identifier: 10603295134176
• UDI-Public: 10603295134176
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2020

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 Model Number: 2545-00-745
• Device Catalogue Number: 254500745
• Device Lot Number: BFA0W7G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 04/05/2020; 04/27/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/08/2020; 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1