MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SELF-TAPPING COMPRESSION SCREW FIXOS Ø3.5MM / L24MM; SCREW, FIXATION, BONE

Catalog Number	CS24A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that during fixation of an mtp, the head of the fixos cs24a screw sheared off of the screw.The distal end of the screw was left in the patient.It was further reported that the surgeon did not pre-drill the bone.Procedure was completed successfully with no surgical delay or adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The visual inspection showed that the screw is broken.Only the head of the screw was received for inspection.The second end was left in the patient as reported in the complaint.More detailed information about the complaint event (such as the x-rays) must be available in order to determine the root cause of the complaint event.However based on the complaint history some potential root causes are the following (but not limited to): misalignment between the k-wire and the screw (bending of the k-wire), screw positioning was not optimal, screw selection was not optimal, conflict with other device or debris, screw insertion method was not optimal.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.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
It was reported that during fixation of an mtp, the head of the fixos cs24a screw sheared off of the screw.The distal end of the screw was left in the patient.It was further reported that the surgeon did not pre-drill the bone.Procedure was completed successfully with no surgical delay or adverse consequences reported.

• Brand Name: CANNULATED SELF-TAPPING COMPRESSION SCREW FIXOS Ø3.5MM / L24MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8935587
• Report Number: 0008031020-2019-01154
• Device Sequence Number: 19586066
• Product Code: HWC
• UDI-Device Identifier: 07613252259077
• UDI-Public: 07613252259077
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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 Catalogue Number: CS24A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1