MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR; FASTENER, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unknown, unknown 1.4mm juggerknot soft anchor, unknown; unknown, unknown 1.4mm juggerknot soft anchor, unknown; unknown, unknown 1.4mm juggerknot soft anchor, unknown; unknown, unknown 1.4mm juggerknot soft anchor, unknown; unknown, unknown 1.4mm juggerknot soft anchor, unknown; unknown, unknown 1.4mm juggerknot soft anchor, unknown; unknown, unknown 1.4mm juggerknot soft anchor, unknown.Report source, literature - nakagawa, s.Et al (2017).Postoperative recurrence of instability due to new anterior glenoid rim fractures after arthroscopic bankart repair.The american journal of sports medicine, 45(12), 2840-2848.Doi: 10.1177/0363546517714476.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01929, 0001825034 - 2018 - 01930, 0001825034 - 2018 - 01931, 0001825034 - 2018 - 01933, 0001825034 - 2018 - 01934, 0001825034 - 2018 - 01935, 0001825034 - 2018 - 01936.Product location unknown.

Event Description

It was reported in a journal article that a patient experienced a new glenoid rim linear fracture along several anchor holes.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; 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: 7347061
• MDR Text Key: 102710461
• Report Number: 0001825034-2018-01932
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2018
• Initial Date FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 16 YR