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Model Number 400-3703-SP |
Device Problem
Break (1069)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.
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Event Description
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It was reported the patient underwent the initial implant procedure for hallux interphalangeal joint fusion on (b)(6) 2022.The surgeon reported the patient had a non-union and one of the two 10 x 10 instafix staples had broken at the corner (event date unknown).On (b)(6) 2022, the surgeon explanted both instafix staples, debrided, fenestrated, added dbm putty, and placed two 15 x 10mm instafix staples.It was indicated the explanted instafix staples were not available to be returned for evaluation.This report is related to report number 2027754-2022-00050 for the other explanted instafix staple.
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Manufacturer Narrative
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Sections d4.Udi and h4.Device manufacture date completed as review of manufacturing and inspection records has been completed.The device was not returned for evaluation.The device history record (dhr) was reviewed for lot 20622992102, and no issues were identified in the dhr review.The instafix kits from lot 20622992102 were issued staples from bulk lot 1161093.All inspections passed and no issues were identified with this bulk lot.A two year review (november 2020 - october 2022) of the complaint database found eight (8) complaints related to the instafix kits.This is the only reported complaint for a broken staple/non-union of bone.Review of the instructions for use (ifu) revealed the warning section states: "the devices can break when subjected to increased loading associated with nonunion or delayed union.Internal fixation devices are load sharing devices that hold a fracture in alignment until healing occurs.If healing is delayed, or does not occur, the implant can be expected to break, deform or fail.Loads produced by weight bearing, and activity levels may dictate the longevity of the implant." follow up with the field revealed "the surgeon did not indicate that he had any theories on what caused the non-union".Based on the information received and the investigation performed, the root cause could not be determined.
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Search Alerts/Recalls
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