MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; PLATE, FIXATION, BONE

Model Number	56-01250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that when drilling with the device the drill got stuck in the sleeve and broke.
Additional Manufacturer Narrative
D1, d4, g4 have been corrected with updated product information.Product return date has been added.The device is still pending investigation.
Event or Problem Description
It was reported that when drilling with the device the drill got stuck in the sleeve and broke.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.The device inspection revealed the following: the received drill bit shows signs of extensive and prolonged usage, also broken from the region from where the cutting edges start.The part with cutting edges was not received for evaluation.Remarkably the breakage was found to be symmetry with no abrupt breakage surface.Some rotational scratch marks were identified on the outer surface around the breakage point.The breakage surface shows rotational pattern and a minor dimple at the centre.The fracture surface resembles a typical ductile fracture due to torsional overload.The shaft diameter of the drill was observed to be 1.99 mm as required against a range of 1.98mm ¿ 2.00mm.The average hardness of the drill bit was observed to be 50.5 hrc as required against a range of 47.0 hrc ¿ 52.0 hrc.The returned drill bit was found to be within specifications.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is user related.The breakage of the drill happened due to a torsional overload, most likely when excessive rotational force was exerted when the drill was stuck in the sleeve.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that when drilling with the device the drill got stuck in the sleeve and broke.

• Brand Name: DRILL BIT, AO DIA2.0MM X 135MM, SCALED
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11787340
• Report Number: 0008031020-2021-00211
• Device Sequence Number: 3972161
• Product Code: HRS
• UDI-Device Identifier: 04546540579980
• UDI-Public: 04546540579980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2021

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: 56-01250
• Device Catalogue Number: 703896
• Device Lot Number: AL02/BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 04/26/2021; 07/01/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/27/2021; 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1