MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH STRAIGHT IMPLANT; SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE

Catalog Number 110024772

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: juggerstitch curved implant cat#110024773, lot#65867720.G2: (b)(6).Visual examination of the returned product identified sample one has been cycled one time and both blue anchors remain in the needle; sample 2 has been cycled 2 times and both blue anchors have been deployed from the needle.For the device that has been cycled twice with both anchors deployed (sample 2), it was noted that a blue fiber is present on the pusher wire; however, it cannot be confirmed where the piece originated from.Unable to verify item/lot information as there are no product identifiers on the product and there was no packaging returned with the devices.However, the device that has been cycled 2 times and has the anchors deployed is a curved front-end assembly and the device that has been cycled once and has retained the blue anchors has a straight front-end assembly.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event of the anchor not deploying for part 110024772 is confirmed from product return.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

It was reported that the anchor didn¿t deploy 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.

• Brand Name: JUGGERSTITCH STRAIGHT IMPLANT
• Type of Device: SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE
• 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: 17756959
• MDR Text Key: 323524418
• Report Number: 0001825034-2023-02176
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304690066
• UDI-Public: (01)00880304690066(17)270929(10)466980
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110024772
• Device Lot Number: 466980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10