MAUDE Adverse Event Report: STRYKER GMBH TIBIAL ALIGNMENT ROTATION SLEEVE STAR ANKLE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number	9330003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the star implant item on the tibial alignment guide was broken.The screw on the sliding block on the proximal end had been sheared and left in the guide, this meant it was unable to be used.Another item was used to complete the case.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, most probably the failure was caused by inappropriate device maintenance/handling and device useful life exceedance.The reported event occurred in 2019 and the device was manufactured on 02-nov-2011, meaning that it has been in working order for almost 8 years, a significant amount of time.The useful life of re-usable medical 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 cleaning and sterilization guide clearly mentions 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.However, for certain instruments end of life has been defined, verified and specified with either a number of uses or an expiration date.Before preparing for sterilization, all medical devices should be inspected.Generally un-magnified visual inspection under good light conditions is sufficient.All parts of the devices should be checked for visible soil and/or corrosion.'' therefore, this case is classified as a user related issue.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.
Event or Problem Description
It was reported that the star implant item on the tibial alignment guide was broken.The screw on the sliding block on the proximal end had been sheared and left in the guide, this meant it was unable to be used.Another item was used to complete the case.

• Brand Name: TIBIAL ALIGNMENT ROTATION SLEEVE 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: 8947011
• Report Number: 0008031020-2019-01193
• Device Sequence Number: 11300481
• Product Code: NTG
• UDI-Device Identifier: 00886385018812
• UDI-Public: 00886385018812
• 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): 11/15/2019

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: Health Professional
• Device Catalogue Number: 9330003
• Device Lot Number: 1325302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1