MAUDE Adverse Event Report: KLS-MARTIN L.P. DISTRACTION, INTERNAL; SCREWDRIVER

Model Number 51-430-95-07

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Skull Fracture (2077)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

Situation: patient had skull fracture along the suture lines in the back of their head requiring unplanned return to the operating room due to the distractors and screwdriver supplied by vendor/manufacture were mislabeled.Background: surgery performed to install two distractors into patient's skull to treat their bilateral coronal craniosynostosis.The distractors were kls martin neonatal mandible distractors.They came with a screwdriver that was used to gradually expand patient's skull.According to the screwdriver's label, one turn would move the distractor 0.3mm.Md determined that each of patient's distractors should be expanded approximately 1mm per day, so that over 25 days each distractor would expand 25mm.Accordingly, you directed us to turn the screwdriver three times each subsequent day, which would expand the distractors 0.9mm each day.For 14 days, the screwdriver was turned three times on each distractor.Md unable to turn the screwdriver any further.The next day, md came in for a follow-up check.Md felt the back of patient's skull, you suspected patient had a stress fracture.Ct scan ordered that day, with results showing that patient suffered a stress fracture, but also showed that the distractors had distracted to the full extent of 25mm instead of the expected 14mm.The increased distraction had stressed patient's skull, leading to a fracture along the suture lines at the back of her skull.This required an additional surgery, which was performed.Assessment: the over-distraction, and resulting stress fracture, happened because the manufacturer that made and supplied the distractors and screwdriver had mislabeled the screwdriver: in fact, the screwdriver had distracted the distractors 0.6mm per turn¿twice the amount as the screwdriver's label said.The result was that we were unknowingly distracting the distractors at twice the expected rate.Request: safety investigation and fda medsun reporting.Risk management notified.Disclosure to parents done.The screwdriver that came in the tray was the wrong size for the tray.The screwdriver worked as it should but was not intended for use on the implanted distractor.A different screwdriver should have been provided for the distractor that was implanted.The screwdriver expanded the distractor at twice the intended rate.The label on the screwdriver indicated it would expand the distractor 0.3mm per 1 full turn.Because it was not intended for the implanted distractor, it expanded the mismatched distractor 0.6mm per 1 full turn.The intended expansion rate was 0.9mm/day.This was to be achieved by making 3 full turns of the screwdriver each day.(0.3mm/1 full turn x3 turns = 0.9mm/day).Although this screwdriver was not intended for use on the implanted device, the parts were compatible allowing it to be used on a distractor it was not intended for.This event had minimal temporary harm.

• Brand Name: DISTRACTION, INTERNAL
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): KLS-MARTIN L.P.; 11201 saint john¿s industrial pkwy s; jacksonville FL 32246
• MDR Report Key: 12370041
• MDR Text Key: 268242677
• Report Number: 12370041
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2021

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
• Device Operator: No Information
• Device Model Number: 51-430-95-07
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 150 DA