MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION TIBIAL BLOCK L; RESECTION BLOCKS/DEVICES

Model Number	2506-10-111
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
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
The hospital have reported dirty instruments on the attune revision set.2 soiled instruments within the general instruments, hospital have cleaned and processed them on.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was not returned for analysis.Review of the photographic evidence confirmed, the reported allegation, due to it was observed, debris inside the holes of the complaint device.No other issues were identified.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Additional information received.Indicated, that there was no surgical delay.As this was discovered, on first sterilization.A few days before the operation.And so, there was time to rectify the situation.

• Brand Name: ATTUNE REVISION TIBIAL BLOCK L
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14548529
• Report Number: 1818910-2022-09807
• Device Sequence Number: 20123292
• Product Code: HTZ
• UDI-Device Identifier: 10603295436225
• UDI-Public: 10603295436225
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022
• 2 Devices were Involved in the Event: 1 2

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: 2506-10-111
• Device Catalogue Number: 250610111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown