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

Model Number	705004
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
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
As reported: "doctor was drilling through 4.0 locking guide with 3.1mm drill bit and noticed the drill bit was getting stuck in guide.The doctor removed the guide from the plate and tried to pass the drill bit through the locking guide.The drill bit wouldn't pass through the locking guide.He used a different locking guide from the axsos 3 4.0 tray and continued the surgery with no adverse effects.".
Event or Problem Description
As reported: "doctor was drilling through 4.0 locking guide with 3.1mm drill bit and noticed the drill bit was getting stuck in guide.The doctor removed the guide from the plate and tried to pass the drill bit through the locking guide.The drill bit wouldn't pass through the locking guide.He used a different locking guide from the axsos 3 4.0 tray and continued the surgery with no adverse effects.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection of the returned device shows that the drill guide has been used and there are marks in the cannulation.These deformations with burrs are typically caused by drilling.The deformations is the reason why the drill did not go through the drill guide.The dimensional inspection using a caliper shows that the outer diameter of the drill guide is 3.15mm, which is according to specifications.The whole batch (60 devices) was inspected 100% for the diameter 3.15 +0.05 and is documented according to specifications.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.Based on the results of the inspection above, the root cause of the event has been identified to be user related.The burrs that hinder the drill were caused by the use of the drill by the user.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: 9689493
• Report Number: 0008031020-2020-00333
• Device Sequence Number: 17044803
• Product Code: LXH
• UDI-Device Identifier: 07613327083606
• UDI-Public: 07613327083606
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 05/04/2020

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: 705004
• Device Catalogue Number: 705004
• Device Lot Number: K0512AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1