MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHORS JUGGERKNOT SINGLE LOADED 1 #2 MAXBRAID-BLUE/WHITE; FASTENER

Catalog Number 912031

Device Problem Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

Cmp-(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.Once the evaluation has been completed, a follow-up mdr will be submitted.(b)(4).Medical products-juggerknot catalog#: 912031 lot#: p04646.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-01682.

Event Description

It is reported during a shoulder arthoscopic surgery, that the anchor pulled out of the patient's bone upon attempted implantation.The procedure was finished successfully with alternative anchors.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The two sutures were returned; however, only one anchor was returned and assembled to the suture.It is unknown which lot number this is associated with.Neither inserter was returned for evaluation.Products were visually examined.The sutures have been cut for both products and both have biomaterial on them indicating attempted use.This confirms that the implants were in the patient; therefore, the complaint is considered confirmed.As the inserters were not returned, it cannot be determined if the inserters were bent or fractured that may have led to the reported event.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: JUGGERKNOT SOFT ANCHORS JUGGERKNOT SINGLE LOADED 1 #2 MAXBRAID-BLUE/WHITE
• Type of Device: FASTENER
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 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: 6419531
• MDR Text Key: 70419591
• Report Number: 0001825034-2017-01681
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK110145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/06/2021
• Device Catalogue Number: 912031
• Device Lot Number: P04006
• Other Device ID Number: REFERENCE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: REFERENCE H10