MAUDE Adverse Event Report: STRYKER GMBH SET SCREW, TI GAMMA3® Ø8X17.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30030822S

Device Problem Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains in patient.

Event Description

As reported: "the gamma 3 set screw was not inserted properly and the operation was completed.Postoperative x-rays showed that the set screw remained inside the body.".

• Brand Name: SET SCREW, TI GAMMA3® Ø8X17.5MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18623703
• MDR Text Key: 334495768
• Report Number: 0009610622-2024-00052
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540374844
• UDI-Public: 04546540374844
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30030822S
• Device Lot Number: K0A9F7D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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