MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TRL BLT SZ 6-8 POR; ATTUNE CEMENTLESS INSTRUMENTS : TIBIAL KEEL PUNCH/BULLET

Model Number	2545-00-185
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
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
It was reported that one of the two wings of the attune non-cemented rp tibial punch broke off while the punch was being impacted into the proximal portion of the patient's tibia.The punch process was completed using the broken punch, since the broken off wing was not discovered until after the punch process had been completed.The surgery time was therefore not extended and both of the broken pieces were retrieved.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was returned for analysis.After the examination of the part, allegation was confirmed, one of the tabs was broken.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.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

• Brand Name: ATTUNE RP TRL BLT SZ 6-8 POR
• Common Device Name: ATTUNE CEMENTLESS INSTRUMENTS : TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13422913
• Report Number: 1818910-2022-02090
• Device Sequence Number: 5047188
• Product Code: JWH
• UDI-Device Identifier: 10603295419730
• UDI-Public: 10603295419730
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2022

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: 2545-00-185
• Device Catalogue Number: 254500185
• Device Lot Number: NW245587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 02/17/2022; 03/21/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 02/19/2022; 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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