MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE SHIM SZ3 6MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500632
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 instruments in consignment trays.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Examination of the returned device confirmed breakage.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 methods: was patient affected: no.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: yes.Product checked: no.Label checked: no.Product pulled from stock for inspection: no.The complaint states broken instruments in consignment trays.A review of complaint databases identified similar complaints received.No devices were returned hence the complaint could not be confirmed.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Update may 10, 2019: received complaint device.The complaint consisted of (b)(4) attune shim sz7 5mm.Examination of the returned device confirms the reported trial breakage.The device is broken into two pieces.All pieces were returned for evaluation.A prior similar evaluation by depuy material science (comact (b)(4).Found the fracture surface is consistent with overload.No material or manufacturing defects were observed that would have contributed to the fracture.A complaint database search on the provided product family identified similar reports which when confirmed were attributed to suspected misuse/misapplication of the device.Based on a similar evaluation, the root cause is attributed to unintended misuse/misapplication of the device and the need for corrective action is not indicated.Complaint trends will be monitored by post market surveillance through sep-419.Depuy synthes considers the investigation closed at this time.Should the product and/or additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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.Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed breakage.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE SHIM SZ3 6MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8357370
• Report Number: 1818910-2019-85286
• Device Sequence Number: 1682914
• Product Code: HWT
• UDI-Device Identifier: 10603295133346
• UDI-Public: 10603295133346
• 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): 02/10/2019

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: 254500632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 06/21/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/13/2019; 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1