MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT ASNIS III Ø3.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702626
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "two k-wires broke at base of flutes while drilling.Fracture fixed but drill tips were left in patient." procedure was completed successfully with no surgical delay or adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since reported devices were returned broken.Visual inspection reveals scuff marks on surface of both drill bits consistent with contact to a hard surface during drilling.Both drills also show distortion on the remainder of the helix on the drill bit and rough surface at the breakage point consistent with an instant breakage from excess load.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, root cause is attributed to breakage due to excess load and is user related.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "two k-wires broke at base of flutes while drilling.Fracture fixed but drill tips were left in patient." procedure was completed successfully with no surgical delay or adverse consequences reported.

• Brand Name: DRILL BIT ASNIS III Ø3.2X300MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8972809
• Report Number: 0008031020-2019-01250
• Device Sequence Number: 13511758
• Product Code: LXH
• UDI-Device Identifier: 04546540112897
• UDI-Public: 04546540112897
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 12/30/2019

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: 702626
• Device Lot Number: 16567Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR