MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO SMALL GAMMA3® Ø4.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13203042
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/21/2019
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
As reported: "during the surgery of medualr interlocking, when the doctor is [making] the perforation for the distal block the drill of 4.2 broke [inside] the patient.The smallest part of the drill was leave inside the patient because was not possible to extract it." procedure was completed successfully with no adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: visual inspection: appearance of the breakage surface, distortion on the remainder of the helix on the drill bit and rough surface at the breakage point the course of the breakage line as well as the absence of plastic deformation indicate a (forced) brittle break of the device due to overload, most likely by bending stresses.The flutes also appear blunt, which may have provided added resistance in cutting through the bone.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Based on the investigation the root cause was attributed to a user related issue.The failure was caused due to overloading of drill ultimately causing breakage due to bending load.A review of the labeling did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.
Event or Problem Description
As reported: "during the surgery of medualr interlocking, when the doctor is [making] the perforation for the distal block the drill of 4.2 broke [inside] the patient.The smallest part of the drill was leave inside the patient because was not possible to extract it." procedure was completed successfully with no adverse consequences reported.

• Brand Name: DRILL, AO SMALL GAMMA3® Ø4.2X300MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9050622
• Report Number: 0009610622-2019-00682
• Device Sequence Number: 19435312
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 01/09/2020

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 Expiration Date: 05/31/2016
• Device Catalogue Number: 13203042
• Device Lot Number: K916233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1