MAUDE Adverse Event Report: STRYKER GMBH TIBIAL BARREL IMPACTOR/ EXTRACTOR STAR ANKLE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number	9200061
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
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
Stryker kit inspection specialist reported that in most circumstances when the star tibial impactor returns in a kit from the customers, the plastic element is broken.
Additional Manufacturer Narrative
The reported event that tibial barrel impactor/ extractor star ankle was alleged of instruments - broken, deformed, worn or scratched' could be confirmed.The returned device shows that one of the 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 history, some possible root causes tht could have lead to this breakage are, but not limited to: application of too much force by the healthcare professional during the use of the device, and/or using the device with an angulation.Inadequate storage conditions which could have lead to mixing heavy devices with lighter ones.Indeed, the cleaning and sterilization guide clearly reminds the user: ¿[.] avoid mechanical damage, e.G.Do not mix heavy devices with delicate ones." natural wear of the device.The cleaning and sterilization guide states: "[.] note: stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.For devices that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.See appendix 2 for further details.[¿] " however, it is important to state that the event involving the reccurent breakages of the black pegs of the tibial barrel impactor/ extractor star ankle has been noticed previously by stryker's surveillance teams, and nc was raised to address these events, and further reduce their occurences.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.
Event or Problem Description
Stryker kit inspection specialist reported that in most circumstances when the star tibial impactor returns in a kit from the customers, the plastic element is broken.

• Brand Name: TIBIAL BARREL IMPACTOR/ EXTRACTOR STAR ANKLE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8660744
• Report Number: 0008031020-2019-00520
• Device Sequence Number: 10835630
• Product Code: NTG
• UDI-Device Identifier: 00886385017983
• UDI-Public: 00886385017983
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 06/18/2019

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: Other
• Device Catalogue Number: 9200061
• Device Lot Number: 1317802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1