MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X3MM, UPPERFACE, (5/PACKAGE); IMPLANT

Catalog Number	50-12003
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
He device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by a company representative that during a surgical procedure the screw broke off at the head of the screw.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a delay.
Additional Manufacturer Narrative
A confirmation of the reported event (intraoperative screw breakage) could not be confirmed since the device was not returned.Further information such as the type of surgery, used blade, and if pre-drilling was performed were requested several times regarding the reported case.No further information could be received.The possible root causes according to corresponding risk management file are: - wrong pilot hole - screw interface due to wrong hole diameter / tapped hole - incorrectly selected / assembled implant / instrument - insufficient/too high bone quality - wrong/missing information - reuse of single-use devices - implant/instrument mix-up - wrong/missing functionality check - improper implant placement (e.G.Arch bar, screw.) - too much / wrong forces between blade, screw, and bone (e.G.Screw head deformation, screw breakage) - usage of self-tapping screw without pilot hole / bone screw without tapping - power tool usage for screw insertion (except qdm) - too much / wrong compression/ torsional/axial forces - wrong rotational speed, unintended loads - bone quality resulting in high torque - improper blade disengaging - collision with other implant or instrument - predrilled hole not deep enough (e.G.Wrong choice of instrument/implant, system mix-up, poorly assembled/used instrument) - powered screw insertion with right angled screwdriver based on statistical evaluation there are no indications for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.
Event or Problem Description
It was reported by a company representative that during a surgical procedure the screw broke off at the head of the screw.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a delay.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X3MM, UPPERFACE, (5/PACKAGE)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7605168
• Report Number: 0008010177-2018-00051
• Device Sequence Number: 1623184
• Product Code: JEY
• UDI-Device Identifier: 37613154170747
• UDI-Public: 37613154170747
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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: 50-12003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1