MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV KEEL PUNCH SZ 3-5; ATTUNE STEMMABLE TIBIA INSTRUMENTS : TIBIAL KEEL PUNCH/BULLET

Catalog Number	250610101
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
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
Tibial broach was found to have bone from a previous case in it.Back table was deemed to be contaminated and trays needed to be reprocessed.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE REV KEEL PUNCH SZ 3-5
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 8115683
• Report Number: 1818910-2018-76630
• Device Sequence Number: 1500392
• Product Code: LRY
• UDI-Device Identifier: 10603295436072
• UDI-Public: 10603295436072
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 250610101
• Device Lot Number: PG264166
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 11/30/2018
• 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: 37 YR