MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS ULTRAFIX MICROMITE STITCHPAK, SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 10301

Device Problem Expiration Date Error (2528)

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

Event Date 04/19/2022

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the, 10301, ultrafix micromite stitchpak, suture was implanted on (b)(6) 2022 during a finger ligament repair procedure and the device was expired.Further assessment found that the procedure was completed without a delay.The circulating nurse did not verify the expiration before the case.The circulating nurse opened the package to the field and did not verify expiration with the scrub nurse.The nurse noticed the expiration date at the end of the case.No prophylactic treatment was given.The doctor plans on leaving the implant in.There was no medical intervention or extended hospitalization for this event.This report is being raised on the basis of injury due to implanting expired device.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence has been provided; therefore the report cannot be verified.Ultrafix rc anchor w/disposable inserter, is intended for a normal operating room environment, including exposure to wet procedures, and body fluids.Packaging and products shall withstand normal stresses during transportation.Minimum package shelf life to be (2) years.Maximum package shelf life to be (5) years.A device history record was requested from the manufacturer; however, it has not been provided to date.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of one report, regarding one device, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0001.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ULTRAFIX MICROMITE STITCHPAK, SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott CT 06716
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott CT 06716
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14414138
• MDR Text Key: 291833724
• Report Number: 1017294-2022-00062
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10301
• Device Lot Number: 09417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic