MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREWS FOR RADIUS PLATE, CROSS-PIN, DIAM.2.7X16MM; PLATE, FIXATION, BONE

Model Number	52-27316
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
During the surgery with matrix smart locking plate, a locking screw did not lock to the plate.The locking screw was exchanged with the new one.The procedure continued and completed without problem.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: 5 matrix locking screws were sent back for investigation, whereas only one screw showed some wear / marks, the other 4 screws were untouched and therefore fully intact.A matrix test plate was used in order to check the locking capability of the returned locking screws.All returned locking screws could be inserted and locked without any difficulties.We found that these locking screws are rather old implants which can only be used within the matrix brand.It should be noted, that these matrix screws are not compatible with any new variax dr plattes.The implants from the matrix and variax brand should not be interchanged.A review of the device history was not possible because the lot number was not communicated.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 attributed to be user related.The failure was caused by user error.If any further information is provided, the investigation report will be updated.
Event or Problem Description
During the surgery with matrix smart locking plate, a locking screw did not lock to the plate.The locking screw was exchanged with the new one.The procedure continued and completed without problem.

• Brand Name: LOCKING SCREWS FOR RADIUS PLATE, CROSS-PIN, DIAM.2.7X16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9434444
• Report Number: 0008031020-2019-02043
• Device Sequence Number: 534178
• Product Code: HRS
• UDI-Device Identifier: 34546540401220
• UDI-Public: 34546540401220
• Combination Product (Y/N): N
• 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): 02/12/2020

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 Model Number: 52-27316
• Device Catalogue Number: 52-27316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1