MAUDE Adverse Event Report: STRYKER GMBH CANNULATED DRILL ASNIS III Ø3.5MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702450
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
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
Attempted to use asnis 5 mm and attempted to pass the drill through the guide pin where the drill stuck halfway.Continued to use it as it was, but then stacked several times afterwards.A black relicile came out after removing the postoperative guide pin.
Additional Manufacturer Narrative
The reported event that cannulated drill asnis iii 3.5mm ao fitting was alleged of 'component/device stuck' could be confirmed.Based on investigation, the root cause was attributed to be user related.The most likely root cause is that the wire was bent and could not be properly aligned with drill cannulation.By forcing and continuing to use it, this has lead to drill bit breakage.The device inspection revealed the tip of the drill is broken.Microscopic inspection revealed a brittle fracture: the breakage is due to a torsional overload (too high torque applied).In addition, marks of usages are visible on the device and flutes are blunt.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.
Event or Problem Description
Attempted to use asnis 5 mm and attempted to pass the drill through the guide pin where the drill stuck halfway.Continued to use it as it was, but then stacked several times afterwards.A black relicile came out after removing the postoperative guide pin.

• Brand Name: CANNULATED DRILL ASNIS III Ø3.5MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7911790
• Report Number: 0008031020-2018-00641
• Device Sequence Number: 16376386
• Product Code: LXH
• UDI-Device Identifier: 04546540112040
• UDI-Public: 04546540112040
• 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): 12/28/2018

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 Catalogue Number: 702450
• Device Lot Number: 00270V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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