MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X70 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5070S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the screw broke off during extraction surgery.The extraction was a planned removal.All debris was removed from the patient's body.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The device inspection revealed that: the received screw is completely broken approx.Midshaft into three ends, head, mid, and lower thread flank.Furthermore, the thread flank was found to be flattened and damaged at the distal end which shows signs of damage.The breakage surface shows a smooth structure and presents the typical structure of a brittle fracture, most likely due to a bending overload.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.Based on the investigation, the root cause was attributed to being user-related.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the screw broke off during extraction surgery.The extraction was a planned removal.All debris was removed from the patient's body.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X70 MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14380776
• Report Number: 0009610622-2022-00186
• Device Sequence Number: 5149570
• Product Code: HSB
• UDI-Device Identifier: 04546540202550
• UDI-Public: 04546540202550
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 1896-5070S
• Device Catalogue Number: 18965070S
• Device Lot Number: K018EA6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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: Unknown