MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 5MM, 150 X 40MM; PIN, FIXATION, THREADED

Catalog Number	50185150S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/10/2019
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
It was reported that when the apex pin was inserted with handpiece around tibial shaft part during external fixation, the tip of the pin (about 6mm) was broken.The tip of the pin was not able to be removed and the pin was inserted other point and the operation was finished.Procedure was completed successfully, and no adverse consequences or surgical delay were reported.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was most probably caused by an over-torque applied while inserting the part.The visual inspection showed that the tip of the device is indeed broken.However, no sign of additional damage is noticed.The microscope investigation showed a fibrous surface, with necking on the borders of the fracture indicating that there has been an extensive stretching of the metal.Such fracture (ductile fracture) occurs when the part is subjected to a large force.The operative technique guide clearly explains how to correctly insert the pin to avoid such an incident: "pin insertion guidelines: when inserting the pin by power, using a low speed will limit the temperature increase, which can cause bone necrosis.Do not use excessive axial force.Figure 2 illustrates apex pin insertion under power.Insert the pins 90° to the long axis of the bone to reduce pull in and push out forces on the pins." furthermore, the operative technique guide mentions the right instruments to be used while inserting these pins for a better control and positioning: "the drill brace is designed for manual pin insertion for better control and reduced insertion temperature.It provides integrated attachments for 3mm & 4mm and 5mm & 6mm pins.Simply by changing the drill handle from one end to the other you gain access to the different attachments." the cutting part of the tip wasn't returned as it stayed in the patient.This case is classified as a user related issue.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.
Event or Problem Description
It was reported that when the apex pin was inserted with handpiece around tibial shaft part during external fixation, the tip of the pin (about 6mm) was broken.The tip of the pin was not able to be removed and the pin was inserted other point and the operation was finished.Procedure was completed successfully, and no adverse consequences or surgical delay were reported.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 5MM, 150 X 40MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8457828
• Report Number: 0008031020-2019-00330
• Device Sequence Number: 16645734
• Product Code: JDW
• UDI-Device Identifier: 04546540434777
• UDI-Public: 04546540434777
• Combination Product (Y/N): N
• PMA/510(K) Number: K001886
• 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): 05/22/2019

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: 04/30/2023
• Device Catalogue Number: 50185150S
• Device Lot Number: Y15054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR