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

Catalog Number 9200061

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The stryker rep reported that the one of the plastic implant holding pegs has broken off the tibial impactor during implantation of the tibial component.

Event Description

The stryker rep reported that the one of the plastic implant holding pegs has broken off the tibial impactor during implantation of the tibial component.

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 user related.The failure was caused by the application of bending forces on the piece that broke.The plate was found broken in two at the passage where the plate got screwed on the impactor.At this point high forces can be applied in case bending will be performed to the attached tibial implant and plate.The breakage surface indicates a spontaneous forced fracture of the material.The plate breakage is attributed to a bending overload (use error).Bending is not necessary to implant the tibial component according to the operative technique.The device inspection revealed the following: one of the the black compression plate tips of the device is indeed completely broken off, at the passage where the plate got screwed on the impactor.Only a little piece of it is still screwed into the device.The missing piece was not returned.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
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8025146
• MDR Text Key: 125936901
• Report Number: 0008031020-2018-00911
• Device Sequence Number: 0
• Product Code: NTG
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9200061
• Device Lot Number: 1522401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 11/22/2018
• Supplement Dates FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other