MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL INSERT IMPACTOR

Model Number	6541-4-813
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
When the surgeon finally hit the real insert, he felt a little contact with the tibial component and peeled off from the black part.All broken pieces were collected.

• Brand Name: TIBIAL INSERT IMPACTOR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10559144
• Report Number: 0002249697-2020-01947
• Device Sequence Number: 1241001
• Product Code: HWA
• UDI-Device Identifier: 07613327240566
• UDI-Public: 07613327240566
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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: 6541-4-813
• Device Catalogue Number: 6541-4-813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other