MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SUBTALAR MBA IMPLANT, 12MM; N/A

Catalog Number 050112

Device Problem Inaccurate Information (4051)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the doctor had to place an mba implant no.12 and when opening the package, they found an mba no.10 inside.The original label on the packaging indicated mba code no.12.The surgery was not suspended, and no.10 was used anyway.This caused the impossibility of using what the patient really needs, which is worth clarifying is a minor, who was intervened in a surgery where the use of this implant no.12.Was indicated.The event led to 20 minutes surgical delay and the product remains implanted.The implant was used to treat hyperpronated foot.

Manufacturer Narrative

The packaging of subtalar mba implant (050112) was returned for evaluation.A review of the lot records was conducted and found no indications of problems that could have caused or contributed to the complaint.Trend analysis: no additional complaints for this failure mode (wrong size implant in package) have been received for lot 202436 since its release in september 2020.As no other complaints have been reported and based on the probable cause documented in the root cause analysis section, it is expected that the event alleged by this complaint was a singular occurrence and that there is no widespread problem with lot 202436 or any other lot manufactured and processed around the same time.Failure analysis: the packaging for the part associated with this complaint was returned for evaluation.The box featured labels identifying the contents as a subtalar mba implant 12mm, p/n 050112, lot 202436.Inside the box was an empty plastic bag which previously held the implant along with several patient labels.The patient labels and the label attached to the plastic bag also identified the contents as p/n 050112, lot 202436.As the alleged wrong size device was implanted during the surgery, it could not be returned.Neither photographs nor other evidence of the wrong size device were provided.As it was not possible to confirm that the implanted device was the wrong size, the alleged complaint could not be confirmed.Root cause: review of the manufacturing history determined that several lots of mba implants in a variety of sizes, including both 10mm and 12mm, were manufactured around the same time as lot 202436.These lots were received in austin for incoming inspection, then shipped out for cleaning, packaging, and sterilization.While line clearance procedures are performed at every step in this process to prevent product mixtures, the most likely root cause for the alleged failure was a product mix-up due to insufficient line clearance during a manufacturing step.

Event Description

N/a.

• Brand Name: SUBTALAR MBA IMPLANT, 12MM
• Type of Device: N/A
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 12132667
• MDR Text Key: 263509033
• Report Number: 1651501-2021-00029
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K960692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050112
• Device Lot Number: 202436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1