MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT SINGLE 1.4MM 1 #1 MB; FASTENER, FIXATION

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical devices: (b)(4), jgrknt single 1.4mm 1 #1 mb, p04415.Report source, foreign ¿ events occurred in (b)(6).Customer has indicated that 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 - 2017 - 11479.

Event Description

It was reported that during surgery the anchors were pulled out without becoming lumped up after the surgeon inserted them into the patient's burr holes.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.Visual review identified some minor damage to the threads of the anchor, indicating use.The anchor is completely separated from the suture.The device is also disassembled from the inserter, further indicating attempted use.Functional testing is not possible as the device was returned disassembled.There are no visual indications that the device should have failed.Without the opportunity to be present at the time of the procedure, root cause cannot be determined.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required 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 SINGLE 1.4MM 1 #1 MB
• 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: 7154253
• MDR Text Key: 96117128
• Report Number: 0001825034-2017-11480
• 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
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/14/2022
• Device Model Number: N/A
• Device Catalogue Number: 912030
• Device Lot Number: P06371
• Other Device ID Number: (01) 00880304477193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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