MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45-27010S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.
Event or Problem Description
As reported: a drill broke when drilling over a sleeve into an elliptical hole during variax dr operation.Then, the second drill was opened, the operation was continued and was completed successfully.
Additional Manufacturer Narrative
Correction: refer to d9/h3 the reported event could be confirmed.The device inspection revealed the following: the tip of the returned drill bit is indeed completely broken off, just at the off last flute at the shaft.Marks on the shaft indicate that the device was handled with large forces (damages from a drill guide).The broken surface really indicates that high applied forces had been evident.The close up views, done by the microscope, indicating though that the surface of the most part of the breakage is homogenous which again indicate conformity to the given specification.Therefore we can state that the root cause of the failure was caused due to too much mechanical force which was applied during drilling (as mentioned possible on an angle), which resulted in the tip breakage as indicated at the last flute (powerful dynamically overload during use).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 investigation, the root cause was attributed to be user related.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: a drill broke when drilling over a sleeve into an elliptical hole during variax dr operation.Then, the second drill was opened, the operation was continued and was completed successfully.

• Brand Name: TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9987335
• Report Number: 0008031020-2020-01390
• Device Sequence Number: 4442072
• Product Code: LXH
• UDI-Device Identifier: 04546540538383
• UDI-Public: 04546540538383
• 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): 08/10/2020

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: 45-27010S
• Device Catalogue Number: 45-27010S
• Device Lot Number: AJ09/BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1