MAUDE Adverse Event Report: STRYKER GMBH SPEEDGUIDE DRILL AO, DIA 2.0MM (L=30MM); PLATE, FIXATION, BONE

Catalog Number	703891
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported through medwatch mw5078484 "drill bit broke while in use.No harm to patient.
Additional Manufacturer Narrative
The reported event that speedguide drill ao, dia 2.0mm (l=30mm) was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by powerful dynamically overload during use.The device inspection revealed the following: the returned speedguide drill ao, dia 2.0mm bit is indeed completely broken off.The close up views, done by the microscope, indicating though that the surface of the breakage is homogenous which again indicate conformity to the given specification.The very front of the tip as well as the cutting edges were still intact though.Therefore we can state that the root cause of the failure was caused due to possible inadequate angulation during drilling, the visible cracks also indicates that too much mechanical force had been applied which finally resulted in the tip breakage (powerful dynamically overload during use).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.
Event or Problem Description
As reported through medwatch mw5078484 "drill bit broke while in use.No harm to patient.

• Brand Name: SPEEDGUIDE DRILL AO, DIA 2.0MM (L=30MM)
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7883249
• Report Number: 0008031020-2018-00610
• Device Sequence Number: 1908672
• Product Code: HRS
• UDI-Device Identifier: 07613327070019
• UDI-Public: 07613327070019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 12/03/2018

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: 703891
• Device Lot Number: AG12 / BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other