MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, FULLY THREADED ASNIS III 4.0X48MM; SCREW, FIXATION, BONE

Model Number	325248
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
"as reported: "dr.Was operating on a female with a trimolecular ankle fracture.Dr.Fixed the medial malleolus using 2 threaded guidewires from the asnis 3 stainless steel tray and utilized 2 partially threaded stainless steel screws to compress the fracture after using the 2.7 cannulated drill bit.Dr.Wanted to compress the syndesmosis joint utilizing 2 fully threaded stainless steel screws from the asnis 3 stainless steel tray.Dr.Placed 2 threaded guidewires through the near and far cortex of the fibula and in the near cortex of the tibia for a total of 3 cortices.Dr.Measured for the screw which was a 40 and drilled with the cannulated 2.7 drill bit.As he entered near tibial cortex, he felt a slight click and we got an x-ray of an unfamiliar object.As we further investigated with fluoroscopic x-ray we predicted that the screw was tearing itself apart.We then proceeded with the distal fully threaded screw and a part of the self tapping tip of the screw fell off during insertion.We found this out using x-ray.We then removed the distal size 48 fully threaded stainless steel screw and replaced it with a new one that was successful.Dr.Removed the 40mm fully threaded screw and was able to get the stainless steel debridement from the medial tibia after much work.Dr.Did not replace the 40mm screw because he didn't trust the integrity of the stainless steel screws.Dr.Proceeded to remove the 48 mm fully threaded screw successfully and left the syndesmosis joint alone and started closing.Spoke to rep.Right side.All pieces of the 40mm screw were removed using a forceps.Intra-op x-ray was used to ensure that no pieces remained in the patient.Surgical delay of approximately 30 minutes with use of tourniquet.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was returned, and is not broken.The device was returned and doesn't show any significant damage.The screw is not broken nor bent.However, the reported implant is of size 4.0 mm and was used on a tibia and fibula bone.The size of screw recommended for these bones on the operative technique is a 5.0mm screw.Furthermore, the operative technique states that : "indications statement: the asnis iii cannulated screw system is intended for fracture fixation of small and long bones and of the pelvis.The system is not intended for spinal use.".Based on this statement, the medical expert says: "[.] it is debatable whether syndesmosis stabilization is included in the above statement.The stabilization of the syndesmosis is actually a treatment for the tibiofibular joint due to soft tissue damage of the ligaments and not a fracture treatment.[.]".Therefore, the use of asnis cannulated screws to treat syndesmosis stabilization could be considered off-label use of the device.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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
"as reported: "dr.Was operating on a female with a trimolecular ankle fracture.Dr.Fixed the medial malleolus using 2 threaded guidewires from the asnis 3 stainless steel tray and utilized 2 partially threaded stainless steel screws to compress the fracture after using the 2.7 cannulated drill bit.Dr.Wanted to compress the syndesmosis joint utilizing 2 fully threaded stainless steel screws from the asnis 3 stainless steel tray.Dr.Placed 2 threaded guidewires through the near and far cortex of the fibula and in the near cortex of the tibia for a total of 3 cortices.Dr.Measured for the screw which was a 40 and drilled with the cannulated 2.7 drill bit.As he entered near tibial cortex, he felt a slight click and we got an x-ray of an unfamiliar object.As we further investigated with fluoroscopic x-ray we predicted that the screw was tearing itself apart.We then proceeded with the distal fully threaded screw and a part of the self tapping tip of the screw fell off during insertion.We found this out using x-ray.We then removed the distal size 48 fully threaded stainless steel screw and replaced it with a new one that was successful.Dr.Removed the 40mm fully threaded screw and was able to get the stainless steel debridement from the medial tibia after much work.Dr.Did not replace the 40mm screw because he didn¿t trust the integrity of the stainless steel screws.Dr.Proceeded to remove the 48 mm fully threaded screw successfully and left the syndesmosis joint alone and started closing.Spoke to rep.Right side.All pieces of the 40mm screw were removed using a forceps.Intra-op x-ray was used to ensure that no pieces remained in the patient.Surgical delay of approximately 30 minutes with use of tourniquet.".

• Brand Name: CANNULATED SCREW, FULLY THREADED ASNIS III 4.0X48MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11152626
• Report Number: 0008031020-2021-00017
• Device Sequence Number: 3878841
• Product Code: HWC
• UDI-Device Identifier: 07613327143713
• UDI-Public: 07613327143713
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K000080
• 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): 03/04/2021

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: 01/31/2023
• Device Model Number: 325248
• Device Catalogue Number: 325248
• Device Lot Number: L55795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR