MAUDE Adverse Event Report: STRYKER GMBH HEADLESS COMPRESSION SCREW FIXOS Ø4.0MM / L46MM; SCREW, FIXATION, BONE

Catalog Number	658046
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
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
Fixos 4.0 pt screw broke at shaft while passing joint like in foot and ankle procedure.
Additional Manufacturer Narrative
The reported event that headless compression screw fixos 4.0mm/l46mm was alleged of 'breakage during surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition unknown.
Event or Problem Description
Fixos 4.0 pt screw broke at shaft while passing joint like in foot and ankle procedure.

• Brand Name: HEADLESS COMPRESSION SCREW FIXOS Ø4.0MM / L46MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8006616
• Report Number: 0008031020-2018-00901
• Device Sequence Number: 13847690
• Product Code: HWC
• UDI-Device Identifier: 07613252707042
• UDI-Public: 07613252707042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133451
• 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,Followup
• Report Date (Section B): 12/14/2018

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 Catalogue Number: 658046
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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