MAUDE Adverse Event Report: STRYKER GMBH CANNULATED LOW COMPRESSION SCREW AUTOFIX Ø2.5 X 22MM; SCREW, FIXATION, BONE

Model Number	141-2522
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
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 an order that : "for the 2 screws that failed to be installed, a declaration of material vigilance was made to the (b)(6)".It's also reported that the screwdriver is broken.
Additional Manufacturer Narrative
Correction: refer to d4-lot #.The reported event could be confirmed.The device inspection revealed the following: the visual inspection showed that the screw is severely damaged.The screw's head shows traces of wear (small deformation), a sign that large forces were applied while inserting the screw.Therefore, this case is classified as a user related issue.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 attributed to be user related.The failure was caused by the mishandling of the device (large forced applied on the part).If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that during an order that : "for the 2 screws that failed to be installed, a declaration of material vigilance was made to the ansm" it's also reported that the screwdriver is broken.

• Brand Name: CANNULATED LOW COMPRESSION SCREW AUTOFIX Ø2.5 X 22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9398378
• Report Number: 0008031020-2019-02027
• Device Sequence Number: 16238660
• Product Code: HWC
• UDI-Device Identifier: 03700586900936
• UDI-Public: 03700586900936
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 141-2522
• Device Catalogue Number: 1412522
• Device Lot Number: Q0297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1