MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW S.T. 3.5X16MM; PLATE, FIXATION, BONE

Catalog Number 338616S

Device Problem Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Customer reported that : "during the procedure, before use, the presence of an anomaly on the thread is noted: presence of a metallic debris." "the excess metal was on the screw when it came out of the package".Procedure was completed successfully, "use of another screw because the defect was detected before use".No consequences for the patient.Surgical delay: "just the time it takes to assess the situation and to take another screw." no additional medical intervention required.

Event Description

Customer reported that : "during the procedure, before use, the presence of an anomaly on the thread is noted: presence of a metallic debris." - "the excess metal was on the screw when it came out of the package" - procedure was completed successfully, "use of another screw because the defect was detected before use" - no consequences for the patient - surgical delay: "just the time it takes to assess the situation and to take another screw." - no additional medical intervention required.

Manufacturer Narrative

The reported event could be confirmed.The device was returned, and a stainless steel wire from manufacturing remained attached to the device.Based on the investigation, the cause was deemed manufacturing related.Review of the device history for the reported lot did not indicate any abnormalities.Based on currently available information, no further action is required at this time.If additional information becomes available, the investigation will be updated.

• Brand Name: CORTEX SCREW S.T. 3.5X16MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10485663
• MDR Text Key: 206569569
• Report Number: 0008031020-2020-02208
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K050512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 338616S
• Device Lot Number: D61747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1