MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNIVERSAL PF STEM TRL 115 X 14; STEM TRIALS

Model Number	96-6884
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
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.Investigation summary: examination revealed the stem trial was return separated from the broach, thus the jammed/seized condition could not be confirmed.Function evaluation of the two mating devices found the stem would not assemble with the broach without the use of excessive force due to severe damage/deformation sustained to the attachment end of the stem trial.The investigation did not establish a need for corrective action.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.
Event or Problem Description
It was reported that during the revision knee surgery the 34mm femoral sleeve broach and 14 x 115 stem trial got stuck and was hard to remove.During that time the revision femoral broach handle came off and landed on the floor.We had to get it re-sterilized.While waiting the surgeon started trying to remove with vice grips and damaged the stem trial and sleeve broach.When we did get the handle back it would not stay attached to the broach so i guess it was damaged as well.All three instruments need replaced.

• Brand Name: UNIVERSAL PF STEM TRL 115 X 14
• Common Device Name: STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11832459
• Report Number: 1818910-2021-10432
• Device Sequence Number: 2989901
• Product Code: HTQ
• UDI-Device Identifier: 10603295496502
• UDI-Public: 10603295496502
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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: 96-6884
• Device Catalogue Number: 966884
• Device Lot Number: MF4351205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1