MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CROWN DRILL IMPLANT EXTRACTION SET Ø5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-6167
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Product was taken to biologics at the hospital.
Event or Problem Description
During a hardware removal of asnis iii 4.0 mm cannulated screws we were using a comical drill ( ref# (b)(4) lot# 1806-6167) due to bone growth around the screw head.Bone became wedged in the drill with the screw and the screw broke.The screw became stuck in the drill along with bone.Upon removing the conical drill and noticing the screw head was gone.Because of the broken screw head dr.Had to leave the remaining portion of the screw in the patient.
Additional Manufacturer Narrative
The reported event that crown drill implant extraction set ø5 mm was alleged of issue (implant - breakage / deformation - other) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the complaint history, some of the possible root causes can be: inadequate handling by the user- failure to follow instructions for use the crown drill is not aligned with the screw axis during pressure application for screw extraction damage of instrument during the cleaning and sterilization process may have led to the bending of the instrument a device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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 manufacturing or design related problems were found during the investigation.
Event or Problem Description
During a hardware removal of asnis iii 4.0mm cannulated screws we were using a comical drill ( ref# k0cf181 lot# 1806-6167) due to bone growth around the screw head.Bone became wedged in the drill with the screw and the screw broke.The screw became stuck in the drill along with bone.Upon removing the conical drill and noticing the screw head was gone.Because of the broken screw head dr.Had to leave the remaining portion of the screw in the patient.

• Brand Name: CROWN DRILL IMPLANT EXTRACTION SET Ø5 MM
• 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: 7507099
• Report Number: 0009610622-2018-00207
• Device Sequence Number: 1528804
• Product Code: LXH
• UDI-Device Identifier: 04546540510037
• UDI-Public: (01)04546540510037
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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 Model Number: 1806-6167
• Device Catalogue Number: 18066167
• Device Lot Number: K0CF181
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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
• Patient Age: 14 YR