MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM; PIN, FIXATION, THREADED

Model Number	5038-2-110
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
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
Navi pin tip broken while drilling in distal of tibia tubercle.Surgical delay distal of tibia tubercle bone loss, because surgeon trying to dig out the broken pin tip.
Event or Problem Description
Navi pin tip broken while drilling in distal of tibia tubercle.Surgical delay distal of tibia tubercle bone loss, because surgeon trying to dig out the broken pin tip.
Additional Manufacturer Narrative
The reported event that self-drilling half pin apex ø 3mm, 110 x 25mm was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The surgeon was operating on the tibia of the patient, but he used two 3 mm apex pins.This is against the guidelines of the operative technique, which clearly states: " [.] pin insertion guidelines among others, the pin diameter influences axial frame rigidity.This is because the stiffness of the pin is a function of the forth power of the diameter5.As a guideline one might use the following diameters:6 ¿ forearm: 3mm (distal) and 4mm (proximal) apex pins ¿ humerus: 5mm apex pins, 4mm in distal fragments ¿ femur and pelvis: 5mm apex pins throughout the entire bone ¿ tibia: 5mm apex pins ¿ ankle: 5mm or 5mm transverse apex pins (page 11) [.] ".Furthermore, the ifu also reminds the user that : "[.] ]ensure that you are familiar with the intended uses, indications/ contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.[.] " and "[.] warning ¿ implant selection and sizing: the correct selection of the fracture fixation appliance is extremely important.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone.The correct implant size for a given patient can be determined by evaluating the patient¿s height, weight, functional demands and anatomy.Every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation.[.]".In this case, the user should have used 5 mm apex pins, which are more adequate for a tibia procedure.The device inspection revealed the following: the pins are indeed broken at approximately 5 mm from the tip of the devices.The pins size is, as reported, 3 mm pins.The tips have been returned as well as the main parts.A microscope investigation shows that the breakage surface presents circular rough lines of overtorque in both samples, proving that the size of the pins used was incorrect, and not adequate for the anatomical part where it was used.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 investigation report will be updated.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7504780
• Report Number: 0008031020-2018-00356
• Device Sequence Number: 1862368
• Product Code: JDW
• UDI-Device Identifier: 07613327091748
• UDI-Public: (01)07613327091748
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K861766
• 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): 07/02/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5038-2-110
• Device Catalogue Number: 50382110
• Device Lot Number: L42063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR