MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE JUGGERKNOT 1.5MM #2 MAXBRAID SINGLE; FASTENER, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Cyst(s) (1800)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).All concomitant devices have the same catalog number: 912031.Foreign country: (b)(6).The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-07122, 0001825034-2017-07123, 0001825034-2017-07120, 0001825034-2017-07125.

Event Description

It was reported a patient has been indicated for revision approximately six months after a bankart repair procedure due to cysts and osteoarthritis.No revision procedure has been reported to date.No current correlation between the product and the issue have been identified.

• Brand Name: JUGGERKNOT 1.5MM #2 MAXBRAID SINGLE
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; po box 587; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7031967
• MDR Text Key: 92036911
• Report Number: 0001825034-2017-07124
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK071704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 912031
• Device Lot Number: P02420
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: JUGGERKNOT 1.5MM #2 MAXBRAID SINGLE LN: 064050; JUGGERKNOT 1.5MM #2 MAXBRAID SINGLE LN: 252500; JUGGERKNOT 1.5MM #2 MAXBRAID SINGLE LN: P02226; JUGGERKNOT 1.5MM #2 MAXBRAID SINGLE LN: P02603
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 77