MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIV REV FEM BROACH 34MM; KNEE INSTRUMENT : BROACHES

Model Number	96-1684
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
(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 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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination revealed the broach was return separated from the stem trial, thus the jammed/seized condition could not be confirmed.Function evaluation of the two mating devices found the stem trial 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.No damage to the attachment end of the broach was identified.Examination of the broach did find the cutting edges of the broach are dull and significantly deformed.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.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).Where the product and lot code was provided, 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: UNIV REV FEM BROACH 34MM
• Common Device Name: KNEE INSTRUMENT : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11574684
• Report Number: 1818910-2021-06217
• Device Sequence Number: 11797147
• Product Code: HTQ
• UDI-Device Identifier: 10603295239826
• UDI-Public: 10603295239826
• 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,Followup,Followup
• 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: 96-1684
• Device Catalogue Number: 961684
• Device Lot Number: ABC16887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 05/17/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 05/14/2021; 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1