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

Model Number	3003-0822S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "while inserting the gamma3 set screw the screw would not engage into the nail.Following multiple attempts the nail was removed and replace and the set screw engage into the new nail" a surgical delay was reported; however the length of the surgical delay was not provided.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "while inserting the gamma3 set screw the screw would not engage into the nail.Following multiple attempts the nail was removed and replace and the set screw engage into the new nail" a surgical delay was reported; however the length of the surgical delay was not provided.
Additional Manufacturer Narrative
Please note correction to h6 component code.The reported event could not be confirmed, since the returned device is found to be fully functional and conforming to specifications.The device inspection revealed the following: the received set screw shows significant threads deformation.The threads appear to splayed and flat.The nylon stopper also shows thread marks & slight degradation which indicates the set screw was able to be inserted to some depth.Sight metal debris is also found to be stuck all over the screw threads.All of this indicates that the set screw was most likely misaligned during insertion, hence damaging the threads.A functional test was performed to check the functionality of the received set screws and the nail.Upon testing it was observed that both the set screw could easily be inserted and removed from the nail.Thus, the reported issue could not be reproduced, hence could not be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The received set screws and the nail could be assembled properly.However, it was observed that the set screw threads were severely damaged which indicates towards an improper insertion in the nail, which most likely is the reason for an inadequate insertion.If any additional information is provided, the investigation will be reassessed.

• Brand Name: SET SCREW, TI GAMMA3® Ø8X17.5MM
• Common Device Name: 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12867649
• Report Number: 0009610622-2021-00802
• Device Sequence Number: 17627663
• Product Code: HSB
• UDI-Device Identifier: 04546540374844
• UDI-Public: 04546540374844
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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 Model Number: 3003-0822S
• Device Catalogue Number: 30030822S
• Device Lot Number: K026C39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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
• Patient Sex: Female