MAUDE Adverse Event Report: OSTEOMED, LLC INSTAFIX IMPLANT KIT, 10X10MM; STAPLE, FIXATION, BONE

Model Number 400-3703-SP

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

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 (1) of the two (2) 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 (2) 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 2027754-2022-00049 for the other explanted instafix staple.

Manufacturer Narrative

The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

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.

• Brand Name: INSTAFIX IMPLANT KIT, 10X10MM
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 15526251
• MDR Text Key: 301016277
• Report Number: 2027754-2022-00050
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00842528104170
• UDI-Public: (01)00842528104170(17)000101(10)20622992102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400-3703-SP
• Device Catalogue Number: 400-3703-SP
• Device Lot Number: 20622992102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female