MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI Ø3.5MM / L30MM; PLATE, FIXATION, BONE

Catalog Number	661430
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
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 was discarded.
Event or Problem Description
It was reported that the heads of two screws twisted off during normal use.Both screwheads snapped at the juncture of the shaft thread transition.As the screws snapped their heads, additional screws had to be added to the plate in order to compensate for the loss of fixation.

• Brand Name: CORTEX SCREW AXSOS 3 TI Ø3.5MM / L30MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7861832
• Report Number: 0008031020-2018-00591
• Device Sequence Number: 16436905
• Product Code: HRS
• UDI-Device Identifier: 07613252580362
• UDI-Public: 07613252580362
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2018

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: Health Professional
• Device Catalogue Number: 661430
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/10/2018
• 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: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 91