MAUDE Adverse Event Report: STRYKER GMBH TIBIAL BARREL IMPACTOR/ EXTRACTOR STAR ANKLE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number	920-0061
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reports a breakage of the tibia-impactor of the star-prothesis.Replacement was available.
Event or Problem Description
The customer reports a breakage of the tibia-impactor of the star-prothesis.Replacement was available.
Additional Manufacturer Narrative
The reported event could be confirmed.Visual inspection: one of the black compression plate tips of the device is completely broken off.Only a little piece of it is still screwed into the device.The missing piece was not returned.Based on investigation, the root cause was attributed to a device design related issue.A corrective action report has been opened in order to further investigate and address this issue for further details.If any further information is provided, the investigation report will be updated.

• Brand Name: TIBIAL BARREL IMPACTOR/ EXTRACTOR STAR ANKLE
• Common Device Name: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9482051
• Report Number: 0008031020-2019-02284
• Device Sequence Number: 1834979
• Product Code: NTG
• UDI-Device Identifier: 00886385017983
• UDI-Public: 00886385017983
• Combination Product (Y/N): N
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 920-0061
• Device Catalogue Number: 9200061
• Device Lot Number: L51763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1