MAUDE Adverse Event Report: OSTEOMED, LLC INSTAFIX IMPLANT KIT, 8X8MM; STAPLE, FIXATION, BONE

Model Number 400-3701-SP

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2022

Event Type  Injury  

Event Description

It was reported during the procedure on (b)(6) 2022, while in the operating room, product was opened and all product stickers were provided to the circulating nurse to record.The instafix staple was implanted in the patient.It was not discovered until after the procedure was completed that the implanted staple had expired on (b)(6) 2022.The instafix staple was implanted during an akin procedure in the proximal phalanx.Post procedure, there have been no adverse patient consequences.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned for evaluation as it was implanted in the patient.The device history record was reviewed and revealed no anomalies.Review of the product label for the device involved in this event confirmed the expiration date of 26 october 2022.A two-year review of complaint history revealed no other complaints related to product expiration.The product instructions for use (ifu) was reviewed, and it was determined the sterility section of the ifu clearly states the device should not be used after the expiration date.

• Brand Name: INSTAFIX IMPLANT KIT, 8X8MM
• 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: 15714465
• MDR Text Key: 302849971
• Report Number: 2027754-2022-00054
• Device Sequence Number: 1
• Product Code: JDR
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2022
• Device Model Number: 400-3701-SP
• Device Catalogue Number: 400-3701-SP
• Device Lot Number: 20622991701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2017
• 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 Age: 76 YR
• Patient Sex: Female