MAUDE Adverse Event Report: STRYKER GMBH CALIBRATED DRILL BIT Ø3.1MM X 285MM, AO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	703585
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the drill bit broke during the drilling process in surgery.The broken part is the drill tip of the drill bit.It was jammed in the near cortical bone of patient.They spent 2-3 minutes to get it out eventually.No dissatisfaction from surgeon was observed despite the incident.No adverse consequences were reported.
Event or Problem Description
It was reported that the drill bit broke during the drilling process in surgery.The broken part is the drill tip of the drill bit.It was jammed in the near cortical bone of patient.They spent 2-3 minutes to get it out eventually.No dissatisfaction from surgeon was observed despite the incident.No adverse consequences were reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since it is broken at the tip.The device inspection revealed the following: the breakage surface presents a smooth surface with a fine grained texture (fatigue zone) and an instantaneous zone (rubbing surface).Such a pattern is consistent with fatigue fracture, which can occur under repeated or fluctuating stresses.Fatigue fractures begin as a microscopic crack or cracks that grow as force is applied repeatedly to a part.This means that the fracture started at a point of origin and progressed across the shaft until the remaining material was no longer strong enough to support the load and it finally broke.This pattern is also consistent with the reported event that the device was used several times.This case can thus be classified as the fatigue of the material of the device due to multiple uses and the high forces to which the product is subjected throughout its useful life.The ¿calibrated drill bit ø3.1mm x 285mm, ao¿ is a device that can experience excessive torque.Such power, in combination with dense bone, and even forceful moves, could deform the drill and lead to such a breakage.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.If any further information is provided, the investigation report will be updated.

• Brand Name: CALIBRATED DRILL BIT Ø3.1MM X 285MM, AO
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8625519
• Report Number: 0008031020-2019-00505
• Device Sequence Number: 11327020
• Product Code: HWE
• UDI-Device Identifier: 04546540694072
• UDI-Public: 04546540694072
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 06/17/2019

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: 703585
• Device Lot Number: KU80405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1