MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION SLEVE IMPACTR; IMPACTORS

Catalog Number	254600424
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
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
It was reported that the instruments appear to have rust on them.Nothing left in patient.These are instruments from nashville set 4 attune revision assembly tray.
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.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 # (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.Investigation summary: examination of the returned device confirms the reported corrosion.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Examination of the returned device confirms corrosion is present on the device.A worldwide complaint database search shows one other reported event (b)(4) of device corrosion for this product code.Although it should be noted that the returned products from (b)(6) medical center associated with (b)(4) were all reported for corrosion.After further review of the returned products associated with these complaint records by the metallurgy department it was determined that the cleaning process as stated in the ifu was not being followed, leading to the corrosion of these devices.It is suspected a very alkaline solution is being used during cleaning based on the corrosion seen on the returned devices.This alkaline solution is suspected to be sitting in the wells of certain devices causing corrosion dripping to spread throughout the case.The laser weld is noted to be corroding more, but was determined not to be the cause of the corrosion on other products.The root cause of the device corrosion is attributed to misuse due to not following the cleaning instructions called out within the ifu.Based on the root cause determination of misuse, the need for corrective action was not indicated.Monitor complaints through sep-419.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Product is in secured storage.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE REVISION SLEVE IMPACTR
• Common Device Name: IMPACTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9247717
• Report Number: 1818910-2019-112632
• Device Sequence Number: 16794211
• Product Code: HWA
• UDI-Device Identifier: 10603295440222
• UDI-Public: 10603295440222
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 254600424
• Device Lot Number: AB4163984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/31/2019; 11/27/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/20/2019; 11/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR