MAUDE Adverse Event Report: STRYKER GMBH CANNULATED DRILL ASNIS III 2.7MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702449
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
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: "the orif procedure was performed using aznis 4.0.During drilling, the tip of the drill was broken.There are no residues left in the patient¿s body.The procedure was continued using aznis iii 5.0 and was completed without any problems.
Event or Problem Description
As reported: "the orif procedure was performed using aznis 4.0.During drilling, the tip of the drill [.] was broken.There are no residues left in the patient¿s body.The procedure was continued using aznis iii 5.0 and was completed without any problems.
Additional Manufacturer Narrative
The reported event that cannulated drill asnis iii ø2.7mm ao fitting was alleged of issue ¿instrument - breakage during implantation¿ could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received cannulated drill asnis shows broken at the tip location.The fracture (open petals pattern) surface shows the appearance (pressure scratches) of a forced rupture resulting while applying more than 20° bending angle plastic deformation could be seen.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 investigation the root cause was attributed to a user related issue.The failure was caused during drilling probably user did not use the k-wire and due to too much bending force applied during drilling (hard bone).If any further information is provided, the complaint report will be updated.

• Brand Name: CANNULATED DRILL ASNIS III 2.7MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9788155
• Report Number: 0008031020-2020-00569
• Device Sequence Number: 19011319
• Product Code: LXH
• UDI-Device Identifier: 04546540112033
• UDI-Public: 04546540112033
• 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): 07/08/2020

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: 702449
• Device Catalogue Number: 702449
• Device Lot Number: 05271V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1