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Model Number 1405-1028 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 12/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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The 28mm, 2.5mm diameter locking screw (1405-1028) is provided to customers within a sterile kit (sk-12) and marked single use.The udi reference is for the sterile kit, sk-12, that the product is distributed with.The device was not returned to the manufacturer.The dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem reported.Based on the comments from the revising surgeon and evaluation of the x-rays, it is likely the screw broke as result of fatigue from placing the screw too distally on the metatarsals.The company will supplement this mdr as necessary and appropriate.Device not returned.
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Event Description
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A request was received by an employee of the company on 12/19/2016 for instruments to utilize in an upcoming revision surgery planned for (b)(6) 2016.The revising surgeon was not the same surgeon as the original surgery completed on (b)(6) 2016.The revision surgery was completed on (b)(6) 2016 and unknown implants (screws and/or plates)were removed as a result of a broken screw that was placed in the original surgery between the metatarsals (m1-m2).The surgeon also commented that there was a 2nd metatarsal fracture and that the m1-m2 screw had been placed too distally likely causing the fatigue fracture of the screw.
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Manufacturer Narrative
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The 28mm, 2.5mm diameter locking screw (1405-1028) is provided to customers within a sterile kit (sk-12) and marked single use.The udi reference is for the sterile kit, sk-12, that the product is distributed with.The device was not returned to the manufacturer.The dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem reported.Based on the comments from the revising surgeon and evaluation of the x-rays, it is likely the screw broke as result of fatigue from placing the screw too distally on the metatarsals.The radiographic evidence submitted with the complaint was re-reviewed on 02/14/2017 and it was determined that the root cause of the screw breaking is most likely a result of non-union of the patient's bone after surgery due to screws being placed in areas and/or using a technique where fusion is not likely to occur.The device is intended for fusion and non-union is a known potential adverse event identified in the instructions for use, (b)(4) provided with the sterile kit.The company will supplement this mdr as necessary and appropriate.
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Search Alerts/Recalls
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