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

Catalog Number	30030822S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned and no additional information was available.A review of the device history for the reported lot did not indicate any abnormalities.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2024-00052
• Device Sequence Number: 19434600
• Product Code: HSB
• UDI-Device Identifier: 04546540374844
• UDI-Public: 04546540374844
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 30030822S
• Device Lot Number: K0A9F7D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown