MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS & CR TRLS SZ 9-10; ATTUNE INSTRUMENTS : INSTRUMENT CASES

Model Number	2545-01-710
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
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 recently the operating room staff has been finding black specs in the sets.They are very small black specs.They asked the operating room to send me samples of these black specs.They were mostly found on the bottom of the trays inside the wrappers.A few times they found specs inside the corner protectors that they used.The inside wrap was white so they are easy to identify.What they found was that the black bumpers on the trays which provides protection was peeling off.Perhaps during the transportation and stacking of trays the bumper material breaks down.Not sure if you have received any other concerns about this issue.
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).Investigation summary: the device associated with this report was not returned and based off of the returned photographs the reported event could not be confirmed.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.

• Brand Name: ATTUNE PS & CR TRLS SZ 9-10
• Common Device Name: ATTUNE INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9842799
• Report Number: 1818910-2020-08272
• Device Sequence Number: 742738
• Product Code: FSM
• UDI-Device Identifier: 10603295423607
• UDI-Public: 10603295423607
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 02/28/2020

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: 2545-01-710
• Device Catalogue Number: 254501710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1