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

Model Number 141-2522

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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.

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 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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9398378
• MDR Text Key: 193322502
• Report Number: 0008031020-2019-02027
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03700586900936
• UDI-Public: 03700586900936
• Combination Product (y/n): N
• PMA/PMN Number: K052576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1