MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFC* FLUT TIB ROD TRL 75 X 14; KNEE INSTRUMENT : TIBIAL STEM TRIALS

Model Number	96-6876
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a knee revision a zimmer lcck was taken out and a tc3 was going to be put in.During the preparation of tibia they had reamed with the 14 mm reamer to the right depth and with the conical reamer and went on to broach with the smallest sleeve broach and the 14 x 75 mm stem attached.During the first broach the tip of the trial stem came off the trial stem and got stuck distally in the patients tibia.It was no chance of retrieving it because it was stuck.The tip of the stem is not possible to loosen but it came off anyway.There was a surgical delay of 45 minutes.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : visual examination of the returned device confirmed the reported event.The device was found broken, not all parts were returned.Depuy synthese 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 (mrae) 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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: KNEE INSTRUMENT : TIBIAL STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14468721
• Report Number: 1818910-2022-09366
• Device Sequence Number: 5175750
• Product Code: HWT
• UDI-Device Identifier: 10603295217589
• UDI-Public: 10603295217589
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 05/23/2022
• 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: 96-6876
• Device Catalogue Number: 866876
• Device Lot Number: TBFCV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 07/19/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/16/2022; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2001
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 80 KG