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

Catalog Number	30030822S
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the set screw got stuck in the middle of the nail and the screwdriver for the set was not turning halfway.When tightened hard, it made a creaking sound and the situation was completely different from usual.We tried a new set screw, but the result was the same.We thought that the nail was not good, removed it, open a new difference nail, and perform the operation.The operation took twice as long as usual, putting a burden on the patient, but it was completed successfully.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The returned set screw was visually inspected in which we can clearly see the damages and deformation on the threads.The thread coating is completely rubbed off and the shape of the thread is also damaged.The damage on the cylindrical portion of the shaft also indicates that it rubbed off with the nail's body and thread which confirms the misalignment.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.The root cause of this occurrence can be attributed to user-related as we can see signs of misalignment.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the set screw got stuck in the middle of the nail and the screwdriver for the set was not turning halfway.When tightened hard, it made a creaking sound and the situation was completely different from usual.We tried a new set screw, but the result was the same.We thought that the nail was not good, removed it, open a new difference nail, and perform the operation.The operation took twice as long as usual, putting a burden on the patient, but it was completed successfully.".

• 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: 18020950
• Report Number: 0009610622-2023-00372
• Device Sequence Number: 6650306
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 30030822S
• Device Lot Number: K02BD41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian