MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 1/8" DRILL W/O STOP - 2/PKG; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 3170-0000

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

The customer reported that the long drill pin sheared in two when drilling through the left tibial cutting block with one part remaining in the pin driver and damaged caused to the left tibial cutting block, in trying to remove the pin.

Manufacturer Narrative

An event regarding damage involving an triathlon drill bit was reported.The event was confirmed.Method and results: device evaluation and results: the visual inspection concluded that spiral scratches are on the shaft of the device, consistent with damage from debris or burrs on the associated guide contacting the drill bit during use.Discussions with the material analysis team determined that a formal material analysis was not required as the mode of failure was readily apparent.They determined the reason the drill became stuck within the guide was due to galling which occurred during use.They noted gouges on a portion of the drill¿s outside diameter to support their conclusions.The galling was confirmed to be consistent with similar events reported for this product and therefore no further evaluation was deemed necessary.The reason for the galling could not be determined.Conclusions: the visual inspection concluded that spiral scratches are on the shaft of the device, consistent with damage from debris or burrs on the associated guide contacting the drill bit during use.The discussions with the material analysis team concluded that the scratches and the damages observed are due to galling between drill and guide which occurred during the use.The galling was confirmed to be consistent with similar events reported for this product and therefore no further evaluation was deemed necessary.The reason for the galling could not be determined.No further investigation for this event is possible at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

The customer reported that the long drill pin sheared in two when drilling through the left tibial cutting block with one part remaining in the pin driver and damaged caused to the left tibial cutting block, in trying to remove the pin.

• Brand Name: 1/8" DRILL W/O STOP - 2/PKG
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5798269
• MDR Text Key: 50437110
• Report Number: 0002249697-2016-02337
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3170-0000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 75