MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, CROSS-PIN, DIAM.2.0X6MM, (5/PACKAGE); IMPLANT

Catalog Number	50-20506
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation as it was discarded by the facility at their location.If additional information is received it will be reported in a supplemental report.
Event or Problem Description
It was reported by a company representative that during a mandible fracture procedure the screw head broke off from the thread part 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
Since the original filing the exact device was determined, which in this supplemental has been reported as a "correction" from an unknown device to the now known 50-20506.The previously provided product code and 510(k) remain the same.Based on the cmf investigation, the reported event could be confirmed.The metal coil was sheared off the screw¿s locking thread.The returned screw was visually inspected.During insertion of the screw with too much axial forces, no proper locking could be achieved.Because of a collision with a hard material (no bone; most likely the plate), a coil/sliver was sheared off the screw.Additionally there are damages on the cross-pin that point to high torsional forces in screw in direction.Based on the evaluation there are no indications for any systematic design, material, or manufacturing-related issue.The complaint is added to the complaint trend.
Event or Problem Description
It was reported by a company representative that during a mandible fracture procedure the screw head broke off from the thread part 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: LOCKING SCREWS, CROSS-PIN, DIAM.2.0X6MM, (5/PACKAGE)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7605089
• Report Number: 0008010177-2018-00050
• Device Sequence Number: 1277435
• Product Code: JEY
• UDI-Device Identifier: 04546540579867
• UDI-Public: 04546540579867
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• 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): 02/28/2019

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: Health Professional
• Device Catalogue Number: 50-20506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1