MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW S.T. SPS Ø4.5X38MM; PLATE, FIXATION, BONE

Catalog Number 601038S

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

As reported: "when inserting the cortical screw during the omega chs surgery, it interfered with the t2alpha retrograde nail that was inserted earlier, causing the cortical screw to break off.Screw shaft side remains inside the body.".

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

• Brand Name: CORTEX SCREW S.T. SPS Ø4.5X38MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18933918
• MDR Text Key: 338553804
• Report Number: 0008031020-2024-00123
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 601038S
• Device Lot Number: H52779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1