MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.5MM #2 MB SNGL; FASTENER, FIXATION

Model Number N/A

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 10/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 912031, jgrknt 1.5mm #2 mb sngl, p05900.912031, jgrknt 1.5mm #2 mb sngl, p05914.912031, jgrknt 1.5mm #2 mb sngl, ni.Report source, foreign ¿ events occurred in (b)(6).Product has been received by zimmer biomet and the investigation is in process.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 - 2017 - 10077.0001825034 - 2017 - 10079.

Event Description

It was reported that during the surgery, the anchors were pulled out when the surgeon tried suturing the sutures.The same incident occurred on three additional products during the same surgery.Therefore, the surgeon had to drill more burr holes and used alternative products to complete the surgery.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The three devices were visually examined and photos were taken.Additional photos were provided by (b)(6) which were also reviewed.There does not appear to be any structural damage to the juggerknot inserters (i.E.Bent, fractured, etc.).It is noted that all three devices are disassembled in that the sutures are no longer assembled to the instruments.Per the complaint, none of the anchors remain in the patient.Only one anchor was returned.It is assumed that the other two anchors were discarded.It is evident from the returned anchor that it was attempted to be deployed.This is seen from the attached photo which shows the anchor has been drawn in on itself and is pulled tight.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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: JGRKNT 1.5MM #2 MB SNGL
• 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: 7023962
• MDR Text Key: 91782376
• Report Number: 0001825034-2017-10078
• Device Sequence Number: 1
• Product Code: JDR
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/21/2021
• Device Model Number: N/A
• Device Catalogue Number: 912031
• Device Lot Number: P04871
• Other Device ID Number: (01) 0 0880304 50962 7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 02/20/2018; 02/22/2018
• Supplement Dates FDA Received: 02/21/2018; 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention