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

Catalog Number 50-12003

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2018

Event Type  malfunction  

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 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.

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 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)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7605168
• MDR Text Key: 111857039
• Report Number: 0008010177-2018-00051
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 37613154170747
• UDI-Public: 37613154170747
• Combination Product (y/n): N
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-12003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1