MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PIN PULLER; ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 254500060

Device Problem Corroded (1131)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2019

Event Type  malfunction  

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 Description

It was reported that these instruments appear to have rust on them.Nothing left in patient - (b)(6) loaner set 2 pinning and spacing.

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.

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).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 other reported events of device corrosion for this product code.Although it should be noted that the returned products from (b)(6) medical center associated with (pc-000569088, pc-000570222, pc-000569090, pc-000569093, pc-000572923, pc-000569249, pc-000571529, pc-000569111) 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.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 PIN PULLER
• Type of Device: ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9262476
• MDR Text Key: 184707357
• Report Number: 1818910-2019-113460
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295130574
• UDI-Public: 10603295130574
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 254500060
• Device Lot Number: PG246433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 11/27/2019
• Supplement Dates FDA Received: 11/21/2019; 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR