MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG CRVD+ INS TRL 2.5 8MM; KNEE INSTRUMENT : TIBIAL TRIALS

Model Number	97-2340
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
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
Trial is worn.Small piece was cracked on underside and noticed while washing in spd.All pieces were recovered.No surgical delay.No adverse affects on the patient.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : the device associated with this report was not returned for analysis.Review of the photographic evidence confirmed the complaint.A piece has broken off from the trial.Additionally, device presents chipping, shredding, scratching and gouging consistent with damage/wear from normal use and servicing over time.The overall condition of the device indicates it has reached the end of its¿ useful life.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.

• Brand Name: SIG CRVD+ INS TRL 2.5 8MM
• Common Device Name: KNEE INSTRUMENT : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14565681
• Report Number: 1818910-2022-09883
• Device Sequence Number: 5082437
• Product Code: HWT
• UDI-Device Identifier: 10603295251033
• UDI-Public: 10603295251033
• 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
• Report Date (Section B): 06/01/2022

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: 97-2340
• Device Catalogue Number: 972340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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