MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MMF SCREWS,2.0X12MM, CROSS-PIN, SELF DRILLING, 4/P; IMPLANT

Catalog Number	50-20362
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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 procedure the screw broke off at the shaft area during insertion.The broken piece was removed.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a delay.
Additional Manufacturer Narrative
The investigation results show that the returned 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 the screw is broken off and was not returned, the other returned fragment¿s chemical composition was tested and conforms to the specification ¿ 1.4441.The fracture of the screw occurred in the fourth thread.The damages on the cross-pin point to high torsional forces in the screw in direction.The changes of the surface¿s structure, as well as, the flow structures in the thread area point to exceeding the material strength due to high torsional forces.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 show concentric flow structures (honeycomb) of a forced rupture, which are a result of too high torsional forces during insertion of the screw.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.No lot number was provided, and 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.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 further reported: ¿(¿) for this case i know now that there was no pre-drilling and we used the black ratchet screw driver handle (62-20290) along with the mmf blade (62-20135).(¿)¿.The used handle and blade are part of the universal fixation system mmf self.-drilling module as the screw under complaint.Therefore, they are intended to be used in combination with the screw under complaint.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.Therefore, no further 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 procedure the screw broke off at the shaft area during insertion.The broken piece was removed.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a delay.

• Brand Name: MMF SCREWS,2.0X12MM, CROSS-PIN, SELF DRILLING, 4/P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8266887
• Report Number: 0008010177-2019-00002
• Device Sequence Number: 19320817
• Product Code: DZL
• UDI-Device Identifier: 34546540732027
• UDI-Public: 34546540732027
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K050535
• 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): 06/05/2019

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: 50-20362
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1