MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 110024773

Device Problems Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Event Description

It was reported that the anchor did not deploy and the device trigger stuck during a procedure.No harm or impact to the patient was reported.Attempts have been made and no additional information on the reported event is available at this time.

Manufacturer Narrative

(b)(4).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.Zimmer biomet will continue to monitor for trends.Associated products: item#110024773; lot#65867330.Item#110024773; lot#65867330.Item#110024773; lot#035060.

Manufacturer Narrative

(b)(4), this follow-up report is being submitted to relay additional information.Visual examination of the returned product identified no etching on the device and no packaging returned.Both anchors remain in the needle and the device was cycled one time.After performing a function check by cycling the push button one time, both anchors came out of the needle.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Anchor deployment issue: a definitive root cause cannot be determined.Button advancement issue: upon conclusion of the investigation, no problem was found with the given device as the push button was function tested determining to not be stuck; therefore, it functioned as intended.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.

Event Description

No further event information available at the time of this report.

• Brand Name: JUGGERSTITCH CURVED IMPLANT
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16780070
• MDR Text Key: 313693603
• Report Number: 0001825034-2023-00873
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304690073
• UDI-Public: (01)00880304690073(17)280202(10)65867741
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110024773
• Device Lot Number: 65867741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Sex: Male