MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE); IMPLANT

Catalog Number	50-20512
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2018
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 a 2.0 locking screw head fractured off during a mandible reconstruction case.The body of screw was left inside the bone.There was no adverse consequence nor delay of surgery reported.
Additional Manufacturer Narrative
The investigation results show that the returned locking screwhead is broken off, so the reported event could be confirmed.The (measurable) dimensions of the returned screwhead 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 investigation shows that the screw was damaged by too high torsional and tensile foces, whereas the torsional forces prevailed, during the insertion.During insertion of the screw no proper locking could be achieved, because of a collision with a hard material (not bone; most likely the plate or a medical instrument).Because of that coils / slivers were sheared off from the screw.The fracture surface of the screw fragment in the edge region demonstrates concentric flow structures of a ductile forced rupture that were caused by too high torsional forces during insertion, whereas the fracture surface in the center shows the appearance of a ductile forced rupture under tensile forces.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.The bottom surface of the screw head shows friction traces point to the fact that the screw contacted the plate and was further forcibly turned.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 lots.However, the investigation steps conducted and the further provided information demonstrate much evidence that the event is not related to a manufacturing issue.To obtain more details about the complained event, the sales rep was contacted.It was reported that the screw hole was pre-drilled with a 1.6mm drill bit (ref# 60-16535) and the blade used was 62-20130.The used drill is part of the orthognathic fixation for 2.0/2.3 mm screws and the blade used is part of the mandible fixation for 2.0/2.3 mm screws.Therefore is appropriate to be used with the affected screws.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 a 2.0 locking screw head fractured off during a mandible reconstruction case.The body of screw was left inside the bone.There was no adverse consequence nor delay of surgery reported.

• Brand Name: LOCKING SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7920225
• Report Number: 0008010177-2018-00094
• Device Sequence Number: 1936831
• Product Code: JEY
• UDI-Device Identifier: 37613154184447
• UDI-Public: 37613154184447
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 50-20512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• 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