MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SMALL BONE FIXATION SYSTEM; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Device Expiration Issue (1216)

Patient Problem No Information (3190)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained, a follow-up mdr will be submitted.Product location unknown.

Event Description

It was reported that an expired knee product was implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Root cause remains unchanged.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause was determined to be use error.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Sterile cert was reviewed and noted the product was gamma sterilized without any deviations.The label sent along with the product was considered to be adequate.The product label is inspected and noted the expiration date is printed as june 2017.Based on the information available, the root cause of the event is determined to be user error as the product was not used before the provided label date.Sterility claims are not provided by zimmer biomet past the expiration date.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that an expired trauma product was implanted during an orif hand procedure.No patient consequences have been reported as a result.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: SMALL BONE FIXATION SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6789927
• MDR Text Key: 82563976
• Report Number: 0001825034-2017-06290
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: SBFS045
• Device Lot Number: AU3899275
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other