MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, LOCKING Ø3.1MM, SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705004
Medical Device Problem Codes	Degraded (1153); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
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 when the drilling was done with drill bit and drill sleeve, the metallic sounded and the drill did not advance further.Therefore, the drill was changed the new one but the same event was occurred.Therefore, the sleeve was changed and the operation was continued.The procedure was completed successfully with no surgical delay or adverse consequences.
Event or Problem Description
It was reported that when the drilling was done with drill bit and drill sleeve, the metallic sounded and the drill did not advance further.Therefore, the drill was changed the new one but the same event was occurred.Therefore, the sleeve was changed and the operation was continued.The procedure was completed successfully with no surgical delay or adverse consequences.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by clear misuse of the instruments.The device inspection revealed the following: the cutting edges of the returned drill bit is indeed completely gone and blunt.Also the cannulations of both drill sleeves are indeed badly damaged / deformed.Close-up images (using the microscope) of the drill bit clearly show that the drill was surely used on an angle.As the metal shaft has been grinded off severely (misuse).Due to these damages, the drill would not pass the cannulation on either drill sleeve any more.Test using a new drill bit were identical, all three instruments are unusable.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: DRILL SLEEVE, LOCKING Ø3.1MM, SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8705175
• Report Number: 0008031020-2019-00631
• Device Sequence Number: 11183837
• Product Code: LXH
• UDI-Device Identifier: 07613327083606
• UDI-Public: 07613327083606
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 705004
• Device Lot Number: K0A8E6D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 78