MAUDE Adverse Event Report: STRYKER GMBH 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45-30005S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
A cannulated drill bit cod.45-0005s broke during the osteosynthesis of tibial malleolus fracture.During the perforation of the malleolus, using the dedicated guidewire, a fragment of the helioid portion of the drill was detached from it and remained in situ.Once the bur has been removed from the malleolus, the damaged helical portion was slightly bent.It was not possible to remove the fragment, but this did not prevent the osteosynthesis of the malleolus with an asnis micro screw d.3.0, as planned.
Event or Problem Description
A cannulated drill bit cod.45-0005s broke during the osteosynthesis of tibial malleolus fracture.During the perforation of the malleolus, using the dedicated guidewire, a fragment of the helioid portion of the drill was detached from it and remained in situ.Once the bur has been removed from the malleolus, the damaged helical portion was slightly bent.It was not possible to remove the fragment, but this did not prevent the osteosynthesis of the malleolus with an asnis micro screw d.3.0, as planned.
Additional Manufacturer Narrative
The reported event that 3.0mm asnis micro, cannulated drill 2.1mm, ao coupling was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much mechanical during the drilling process (possibly too much angulation during drilling).Unfortunately no further details could be obtained despite multiple attempts.The device inspection revealed the following: the tip of the returned drill bit is indeed badly bent / stripped and almost completely broken off.These damages clearly indicate that far too much mechanical force (possibly drilling on an angle) had been applied during drilling and caused the damages of the tip (caught up on the guide wire).The ao coupling part is still intact though.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: 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7481295
• Report Number: 0008031020-2018-00348
• Device Sequence Number: 11250221
• Product Code: LXH
• UDI-Device Identifier: 04546540534217
• UDI-Public: (01)04546540534217
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/10/2018

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: 45-30005S
• Device Catalogue Number: 45-30005S
• Device Lot Number: 6000067492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other