MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX 5MM, 150 X 50MM; PIN, FIXATION, THREADED

Model Number 5018-6-150S

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The customer reported that during external fixation for a bimalleolar ankle fracture, during insertion/drilling with the above self-tapping external fixation pin, the tip fractured from the rest of the pin, leaving approximately 16 mm of the tip of the pin embedded in cortical bone.The pin fracture was identified immediately and the surgeon elected to leave the retained fragment in the bone.No adverse effects have been noted to date.

Manufacturer Narrative

Correction: refer to d4 lot number the reported event could be confirmed.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.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 be user related.The failure was most probably caused by an over torque applied while inserting the part.If any further information is provided, the investigation report will be updated.

Event Description

The customer reported that during external fixation for a bimalleolar ankle fracture, during insertion/drilling with the above self-tapping external fixation pin, the tip fractured from the rest of the pin, leaving approximately 16 mm of the tip of the pin embedded in cortical bone.The pin fracture was identified immediately and the surgeon elected to leave the retained fragment in the bone.No adverse effects have been noted to date.

• Brand Name: SELF-DRILLING HALF PIN APEX 5MM, 150 X 50MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9689275
• MDR Text Key: 193362443
• Report Number: 0008031020-2020-00320
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 04546540434807
• UDI-Public: 04546540434807
• Combination Product (y/n): N
• PMA/PMN Number: K001886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 5018-6-150S
• Device Catalogue Number: 50186150S
• Device Lot Number: Y54678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR