MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOTLESS SS SINGLE; PROSTHESIS, SPORTSMED

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 110005198; juggerknotless ss single; lot# 387010, item# 110005198; juggerknotless ss single; lot# 655320, item# 110005198; juggerknotless ss single; lot# 756130, item# 912031; jgrknt 1.5mm #2 mb sngl; lot# p12640.Report source: (b)(6).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05759, 0001825034-2019-05761, 0001825034-2019-05764, 0001825034-2019-05765.Product not returned.
Event or Problem Description
It was reported that during a shoulder stabilization procedure on an eighteen year old male patient, the anchors of the juggerknot pulled out.Attempts have been made and additional information on the reported event is unavailable at this time.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
Five inserters were returned but no anchors were; all of the inserters are visually conforming to print.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during a shoulder stabilization procedure on an eighteen year old male patient, the anchors of the juggerknot pulled out.This led to a surgical delay of greater than one hour.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: JUGGERKNOTLESS SS SINGLE
• Common Device Name: PROSTHESIS, SPORTSMED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9585919
• Report Number: 0001825034-2019-05754
• Device Sequence Number: 3389146
• Product Code: MBI
• UDI-Device Identifier: 00880304683822
• UDI-Public: (01)00880304683822
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 110005198
• Device Lot Number: 640420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR