MAUDE Adverse Event Report: STRYKER GMBH TALAR A/P CUT GUIDE LEFT, SM STAR ANKLE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number	9080165
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/23/2019
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
Upon incoming inspection, handle was broken.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the returned product shows that a drill pin broke inside the distal hole that was supposed to host it.Furthermore, it can be noticed that certain areas of the "walls" of the slots where the anterior chamfer reamer is supposed to operate are grated - most probably because of an inadequate use of the reamers.This device is not functional anymore since the distal pin hole that allows the cutting guide to be properly positioned is jammed with the remaining of a broken pin.After the analysis of the product, it was possible to determine that the root cause of the reported event is a mishandling of the device by the user.The jamming of the distal hole is due to the breakage of a pin, most probably because of the application of too much force on it.The grating of the sides of the device is also a result of misuse of the chamber or the use of a sideway drill.As a reminder, the ifu clearly reminds the user: "only implant the star ankle after adequate training and familiarity with the surgical technique manual, to avoid increased risk of device failure due to improper surgical technique", as well as: "examine instruments for wear or damage before use.While rare, intra-operative instrument breakage may occur.Instruments that have experienced excessive use or force may be susceptible to breakage." 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
Upon incoming inspection, handle was broken.

• Brand Name: TALAR A/P CUT GUIDE LEFT, SM 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: 8605815
• Report Number: 0008031020-2019-00489
• Device Sequence Number: 2522415
• Product Code: NTG
• UDI-Device Identifier: 00886385017471
• UDI-Public: 00886385017471
• 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): 06/17/2019

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: 9080165
• Device Lot Number: 1000801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1