MAUDE Adverse Event Report: STRYKER GMBH 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING; BIT, DRILL

Catalog Number	45-30005S
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the drill tip twisted and broke when the bone was hard and force was applied during drill use.A portion of the damaged drill tip is left in the patient.The other drill tip was then used and the procedure continued without problems.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported the drill tip twisted and broke when the bone was hard and force was applied during drill use.A portion of the damaged drill tip is left in the patient.The other drill tip was then used and the procedure continued without problems.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: during visual inspection both k-wire and cannulated drill were found severely deformed and damaged.Both were severely stuck into each other in the deformed condition.The drill was found broken and the remaining flutes were wrapped around the k-wire.Impressions of the drill are clearly visible on the surface of the k-wire which indicates that the internal drill portion came in exact contact with the k-wire prior to the failure and broke due to application of excess torsional force on it while drilling.This is most probably due to the deformation of the k-wire either prior to drilling because the bone could not be hard and excess force applied while inserting the k-wire or during drilling due to misalignment with the drill itself.Furthermore, a hardness test according to rockwell on the returned drill indicates the material being in accordance with the values in the material specification.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 event was caused due to application of excess force on the device when it was misaligned during usage.If more information becomes available, the case will be reassessed.

• Brand Name: 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19620255
• Report Number: 0008031020-2024-00255
• Device Sequence Number: 12813166
• Product Code: HTW
• UDI-Device Identifier: 04546540534217
• UDI-Public: 04546540534217
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: B114148
• 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): 10/01/2024

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: 45-30005S
• Device Lot Number: 6000104810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male