MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T10, 3.5X12MM; PLATE, FIXATION, BONE

Catalog Number	40-35612S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device not available to stryker.
Event or Problem Description
During variax surgery, the screw did not lock in a plate.The screw was replaced with another screw and it locked properly.
Additional Manufacturer Narrative
The event did not involve a product problem indicating a non-conformity, adverse trend or unanticipated hazard.Product surveillance will continue to monitor complaints of this type for adverse trends.
Event or Problem Description
During variax surgery, the screw did not lock in a plate.The screw was replaced with another screw and it locked properly.

• Brand Name: LOCKING SCREW, T10, 3.5X12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7612021
• Report Number: 0008031020-2018-00472
• Device Sequence Number: 1186951
• Product Code: HRS
• UDI-Device Identifier: 04546540539403
• UDI-Public: 04546540539403
• 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): 12/12/2018

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: Lay User/Patient
• Device Expiration Date: 03/04/2023
• Device Catalogue Number: 40-35612S
• Device Lot Number: 1000293299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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