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

Model Number 3125-0170S

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2022

Event Type  malfunction  

Event Description

As reported: "the set screw got stuck.".

Manufacturer Narrative

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

Manufacturer Narrative

Please note corrections to sections d1, d4 catalog#, gtin, g4 510(k) and h6 (health impact code).The reported event could be not confirmed, since the product was returned for evaluation and does not match the alleged failure mode.The device inspection revealed the following: the received set screw exhibits signs of misaligned insertion with the nail, as evident by the unusual thread marks all over the surface of the set screw, followed by subsequent material erosion (shiny surface-material chip off).Pre-surgical test was conducted using the returned set screw with sample trochanteric nail.It was observed that the screw could be assembled and disassembled easily without any difficulty.No indications of material, manufacturing or design related problems were found during the investigation.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.The instructions for use instructs user that: ¿during the course of the operation, repeatedly check to ensure that the connection between the implant and the instrument, or between the instruments, required for precise positioning and fixing is secure.¿ based on the above investigation and provided information, the root cause was attributed to user related issue.The failure was caused by improper usage of the device.If any further information is provided, the complaint report will be updated.

Event Description

As reported: "the set screw got stuck.".

• Brand Name: SET SCREW, TI GAMMA3® Ø8X17.5MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 13596087
• MDR Text Key: 288139339
• Report Number: 0009610622-2022-00069
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3125-0170S
• Device Catalogue Number: 30030822S
• Device Lot Number: K0E6501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2021
• 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