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

Catalog Number	9200061
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Upon incoming inspection it was noticed that the device was broken and unusable.No further information available.
Event or Problem Description
Upon incoming inspection it was noticed that the device was broken and unusable.No further information available.
Additional Manufacturer Narrative
The reported event could be confirmed.More detailed information about the complaint event such as the two broken parts must be available in order to determine the root cause of the complaint event.Indeed, the reason the breakage happened can only be specifically determined after analyzing the surface breakage of the pegs.However, based on complaint history review, the most probably root cause is (but is not limited to) the application of bending forces on the pieces that broke.At the points where the pegs are normally located, high forces can be applied in case bending is performed between the attached tibial implant and plate.Bending is not necessary to implant the tibial component according to the operative technique guide.The device inspection revealed the following: the returned device indeed shows that the two plastic sub-parts that are screwed to the plateau, and which hold the tibial component are broken, making the device unusable.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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: 8434717
• Report Number: 0008031020-2019-00281
• Device Sequence Number: 16593272
• Product Code: NTG
• UDI-Device Identifier: 00886385017983
• UDI-Public: 00886385017983
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: No Information
• Device Catalogue Number: 9200061
• Device Lot Number: 1423902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1