MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T10, 3.5X18MM; PLATE, FIXATION, BONE

Catalog Number	40-35618S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
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
The locking screw was chosen with the fibra plate, and used.It occurred that prevented locking event.Because there might be a problem with the screw, opened a new screw of the same size.However, because could not lock it, it was not used for this screw hole, and the operation ended.
Additional Manufacturer Narrative
The reported event that locking screw, t10, 3.5x18mm was alleged of 'no locking effect' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much applied mechanical force during screw insertion / final tightening.The device inspection revealed the following: a close up of the returned screw, done by the microscope, shows the damages / deformations of the locking threads.Note that the entire lower thread is indeed completely ripped / broken off during insertion / final locking.The damages indicate that far too much force had been applied during final tightening.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The locking screw was chosen with the fibra plate, and used.It occurred that prevented locking event.Because there might be a problem with the screw, opened a new screw of the same size.However, because could not lock it, it was not used for this screw hole, and the operation ended.

• Brand Name: LOCKING SCREW, T10, 3.5X18MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8210626
• Report Number: 0008031020-2019-00002
• Device Sequence Number: 2037892
• Product Code: HRS
• UDI-Device Identifier: 04546540539434
• UDI-Public: 04546540539434
• Combination Product (Y/N): N
• PMA/510(K) Number: K063875
• 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): 02/25/2019

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 Expiration Date: 12/03/2023
• Device Catalogue Number: 40-35618S
• Device Lot Number: 1000294101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other