MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT Ø2.0MM X 122MM AO FITTING FOR 2.7MM SCREW; PLATE, FIXATION, BONE

Catalog Number	703701
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
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
In an elbow surgery the drill 703701 was broken.The part of the drill left inside the patient.The doctor try to get out of the patient but he didnt can take it out.The broken part was left in the muscle of the patient, because when the drill broke they introduce the screw and by the other side of the bone the broken part go out the bone.
Additional Manufacturer Narrative
The reported event that drill bit ø2.0mm x 122mm ao fitting for 2.7mm screw 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 repeated powerful dynamically overload during use.The device inspection revealed the following: the visual examination revealed that the tip of the returned drill bit is indeed completely broken off, the characteristics indicate a typically torsional overload breakage.The fracture surface clearly indicates that too much applied force has finally led to the tip breakage, keep in mind that the drill shaft is slightly bent.Also some spiral traces on the drill shaft are clearly evident (which again indicate drill angulation and damages caused by the drill sleeve housing).Therefore we can determine that the root cause of the failure was due to repeated powerful dynamically overload during use over the years.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
In an elbow surgery the drill 703701 was broken.The part of the drill left insie the patient.The doctor try to getout of the patient but he didnt can take it out.The broken part was left in the muscle of the patient, because when the drill broke they introduce the screw and by the other side of the bone the broken part go out the bone.

• Brand Name: DRILL BIT Ø2.0MM X 122MM AO FITTING FOR 2.7MM SCREW
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8121800
• Report Number: 0008031020-2018-01012
• Device Sequence Number: 13845188
• Product Code: HRS
• UDI-Device Identifier: 07613154973422
• UDI-Public: 07613154973422
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K170727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: Other
• Device Catalogue Number: 703701
• Device Lot Number: 01706J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 02/21/2019
• 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