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
Upon completion of the investigation any additional information will be communicated 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.
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 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 with its tip found to be broken.The part with cutting edges was not received for evaluation.The breakage surface resembles a typical brittle fracture surface predominantly.However, slight permanent deformation was observed around the edges.All these observations are indicative of the fact that the drill was used with high bending and torsional loading.The average hardness of the reduction clamp was observed to be 47.9 hrc as required against a range of 47.0 hrc ¿ 52.0 hrc.The returned screwdriver 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 combined torsional and bending overload.If any additional information is provided, the investigation will be reassessed.

• 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: 11794429
• Report Number: 0008031020-2021-00213
• Device Sequence Number: 16399222
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/07/2021
• 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