MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X6MM, UPPERFACE, (5/PACKAGE); IMPLANT

Catalog Number	50-12006
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by the company representative that the surgeon was tightening the screw when it broke.A new hole had to be used to complete the procedure.No significant delay nor medical intervention was reported, and the surgery was completed successfully.
Additional Manufacturer Narrative
The investigation results show that the returned screw head is broken off, so the reported event could be confirmed.The (measurable) dimensions of the returned screw head are in accordance with the specifications.Because a fragment of screw is broken off and was not returned, the other returned fragment¿s chemical composition was tested and conforms to the specification ¿ tial6v4 (ti grade 5).The orientation of the flow structures of the fracture surface as well as the orientation of the flow structures on the area of the thread shows the screw broke during insertion.The damages on the cross-pin point to high torsional forces in screw out direction.Based on the results of the sem examination it can be excluded that the damages on the cross pin are the cause for the screw breakage.The fracture surface of the screw fragment demonstrates concentric flow structures of a ductile forced rupture that were caused by too high torsional forces during insertion.The investigations with the sem also shows concentric flow structures (honeycomb) of a forced rupture, which are a result of too high torsional forces during insertion of the screw.No lot number was provided, thus a review of the specific manufacturing batch record and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore it is also not possible to determine the quantity released for distribution within the affected lot.The used drill is part of the 1.2 upper face module as the complained screw.It is designed to be used with 1.2 mm screws with length up to 6 mm and therefore is appropriate to be used with the affected screws.A pre-drilled hole that is not deep enough can contribute to the screw shearing off due to increased torque.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.
Event or Problem Description
It was reported by the company representative that the surgeon was tightening the screw when it broke.A new hole had to be used to complete the procedure.No significant delay nor medical intervention was reported, and the surgery was completed successfully.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X6MM, UPPERFACE, (5/PACKAGE)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7920220
• Report Number: 0008010177-2018-00093
• Device Sequence Number: 1798054
• Product Code: JEY
• UDI-Device Identifier: 37613154157342
• UDI-Public: 37613154157342
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/29/2019

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: 50-12006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1