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 Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
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
As reported: "black piece on the inserter broke as the surgeon tried to implant the tibial component.Inserter was removed and the surgeon use the joint space evaluator to push and implant the tibial component.No adverse consequences.However, it delayed the case".
Event or Problem Description
As reported: "black piece on the inserter broke as the surgeon tried to implant the tibial component.Inserter was removed and the surgeon use the joint space evaluator to push and implant the tibial component.No adverse consequences.However, it delayed the case".
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.Based on investigation, the root cause was attributed to be wear related.The failure was caused by the normal wear of the device after being used for more than 5 years.Indeed, it is stated in the cleaning and sterilization guide that:: " [.] 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.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.[.]".The device inspection revealed the following: the black compression plate tips of the device is indeed completely broken off.Only a little piece of it is still screwed into the device.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 7966722
• Report Number: 0008031020-2018-00801
• Device Sequence Number: 11197296
• Product Code: NTG
• UDI-Device Identifier: 00886385017983
• UDI-Public: 00886385017983
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 12/18/2018

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 Catalogue Number: 9200061
• Device Lot Number: 385430
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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
• Patient Age: 51 YR