MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW T8, 2.7MM / L46MM; SCREW, FIXATION, BONE

Model Number	656446
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported the surgeon was using the variax mini fragment to repair an ankle fracture.The surgeon use a 10 hole 2.7mm broad plate and began to populate the plate using the t8 2.7mm screws.The surgeon went to do a 2.7mm syndesmotic screw through the plate, the fibula, and the tibia.He drilled a 2.0mm pilot hole and measured a 2.7x46mm screw.He inserted the screw on power and then switch to the small, blue, asnis micro screwdriver handle.As he final seated the screw the screw head sheared off the shaft of the screw.The screw head was retrieved, but the shaft remained embedded in the bone.The surgeon used a different screw to finish the procedure.
Additional Manufacturer Narrative
Correction: h6 clinical signs code the reported event could be confirmed, since the screw is broken as complained.The device inspection revealed the following: this visual inspection has shown that the screw head is broken off at the crossover from the shaft to the head.There are very strong damages at the t8 recess visible.The strong damages at the recess indicate that the device was exposed to excessive forces before it broke.In addition it can be pointed out that both sides of the t8 recess lips are damaged.This shows that the screw was exposed to high forces in both directions, insertion and extraction.There is just a small part of the fracture face visible at the bottom of the head, the rest of the fracture face is strongly damaged, it looks like the broken head was turned several times on the screw shaft after is was broken.The discolored surface around the fracture shows that there was a plastical deformation before the head broke off.All these point to a ductile overload fracture caused by a mechanical overload.The visible excessive scratches at the side of the screw head may also have played a certain role as there was apparently a strong contact with another 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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a mechanical overload during the usage of the screw.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported the surgeon was using the variax mini fragment to repair an ankle fracture.The surgeon use a 10 hole 2.7mm broad plate and began to populate the plate using the t8 2.7mm screws.The surgeon went to do a 2.7mm syndesmotic screw through the plate, the fibula, and the tibia.He drilled a 2.0mm pilot hole and measured a 2.7x46mm screw.He inserted the screw on power and then switch to the small, blue, asnis micro screwdriver handle.As he final seated the screw the screw head sheared off the shaft of the screw.The screw head was retreived, but the shaft remained embedded in the bone.The surgeon used a different screw to finish the procedure.

• Brand Name: BONE SCREW T8, 2.7MM / L46MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12512754
• Report Number: 0008031020-2021-00418
• Device Sequence Number: 16419280
• Product Code: HWC
• UDI-Device Identifier: 07613327462395
• UDI-Public: 07613327462395
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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 Model Number: 656446
• Device Catalogue Number: 656446
• Device Lot Number: 1000399493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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 Age: 21 YR
• Patient Sex: Female