MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG HP REV TC3 BOX TRIAL SZ4; KNEE INSTRUMENT : FEMORAL TRIALS

Model Number	2011-03-014
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
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 the tc3 box instrument would not screw into the femoral trial.No pieces were broken off.Instrument is being sent back in its entirety.Event did not cause delay to surgery.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : examination of the returned device confirmed the reported damage.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SIG HP REV TC3 BOX TRIAL SZ4
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11012059
• Report Number: 1818910-2020-26974
• Device Sequence Number: 17129795
• Product Code: LXH
• UDI-Device Identifier: 10603295081357
• UDI-Public: 10603295081357
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/30/2020

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: 2011-03-014
• Device Catalogue Number: 201103014
• Device Lot Number: SO2002015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 11/30/2020; 01/05/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 12/21/2020; 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR