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

Model Number	703896
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that 3 drill bits broke off during a distal radius surgery.The surgery was completed with a replacement.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.More information as well as the affected device must be returned to determine the exact root cause of the event.However, based on the past complaints, it is observed that most common cause of failure is user related, when a surgeon tries to apply too much of force (torsional and bending) on the drill to appreciate through the bone.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that 3 drill bits broke off during a distal radius surgery.The surgery was completed with a replacement.

• 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: 11803707
• Report Number: 0008031020-2021-00217
• Device Sequence Number: 14364015
• Product Code: HRS
• UDI-Device Identifier: 07613327070064
• UDI-Public: 07613327070064
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 703896
• Device Catalogue Number: 703896
• Device Lot Number: AK01/BB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 70