MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE? MTP, LEFT ANCHORAGE; PLATE, FIXATION, BONE

Catalog Number	PLP14341
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that during a procedure when the screw was inserted into the locking plate, it stripped the thread of the plate so that the plate would no longer lock.It was further reported that the correct guide, screw and drill bit were used.The plate was discarded and a new one was used to successfully complete the procedure.
Event or Problem Description
It was reported that during a procedure when the screw was inserted into the locking plate, it stripped the thread of the plate so that the plate would no longer lock.It was further reported that the correct guide, screw and drill bit were used.The plate was discarded and a new one was used to successfully complete the procedure.
Additional Manufacturer Narrative
The reported event could be confirmed.Device evaluation: the visual inspection showed that the holes of the plate are severely damaged.This fact clearly shows that large forces were applied while inserting the screws.Moreover, the right distal hole is acutely damaged.The threading part is partially deformed, showing that the screw was inserted in a large angle ( above the maximum of 15°) leading to the thread's plate to strip off.In order to avoid this kind of event, the operative technique mentions that "applying excessive torque during screw insertion is not recommended, and may result in damage to the screw head.In particular for nonlocking screws it is recommended to tighten the screw head until contact with the plate, then release from tightening." and also that "threaded holes accept either 3.0mm or 3.5mm locking or nonlocking screws.Nonlocking screws can be angulated 15° from center".A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was therefore attributed to be user related.The failure was caused by the mishandling of the device.If any further information is provided, the investigation report will be updated.

• Brand Name: CROSS PLATE? MTP, LEFT ANCHORAGE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9333093
• Report Number: 0008031020-2019-01729
• Device Sequence Number: 19300920
• Product Code: HRS
• UDI-Device Identifier: 07613252260554
• UDI-Public: 07613252260554
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083447-LTF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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 Expiration Date: 10/31/2023
• Device Catalogue Number: PLP14341
• Device Lot Number: Y53135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/16/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1