MAUDE Adverse Event Report: STRYKER GMBH SCALED DRILL Ø2.5MM, AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	705031S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/14/2019
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
The customer reported that the patient was undergoing fixation of tibial plateau fracture.While drilling the drill bit fractured and approximately 2cm (nearly all of the fluted section remained in the bone.A decision was taken to leave the drill bit fragment in situ.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the inspection confirms the drill to be broken.Distortion on the remainder of the helix on the drill bit and rough surface at the breakage point as well as a contour line/malformation of device which are consistent with an instant breakage due to excess torsion load.The event reports that an axsos tibial plateau procedure was conducted using the drill bit.The operative techniques for the axsos proximal tibia system and the pro pelvis system were reviewed, confirming that drill bit with catalog number 703966 (2.5mm/l450) is recommended for pro pelvis procedures but not listed as a recommended axsos tibial plateau procedure drill bit.A review of the device history for the reported lot did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by off-label use.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported that the patient was undergoing fixation of tibial plateau fracture.While drilling the drill bit fractured and approximately 2cm (nearly all of the fluted section remained in the bone.A decision was taken to leave the drill bit fragment in situ.

• Brand Name: SCALED DRILL Ø2.5MM, AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9099822
• Report Number: 0008031020-2019-01297
• Device Sequence Number: 3445230
• Product Code: LXH
• UDI-Device Identifier: 07613327083330
• UDI-Public: 07613327083330
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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 Model Number: 705031S
• Device Catalogue Number: 703966
• Device Lot Number: KU91493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1