MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK JUGGERSTITCH; SOFT-TISSUE/MESH ANCHOR

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Pain (1994); Foreign Body In Patient (2687); No Information (3190)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported by the legal team that the patient underwent a surgical procedure involving an unknown juggerstitch device.Subsequently, the patient is experiencing unverified issues.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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

(b)(4).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 further reported that after the patient reported pain an x-ray was completed and it was found that a foreign body was in the soft tissue.The needle from on of the meniscal repair devices broke off in the knee and is sitting posterior to the medial meniscus.The foreign body was removed 10 days after the initial surgery.No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was confirmed per the x-rays that were reviewed as there was a foreign body in the posteromedial soft tissue.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Additional information does not change the root cause of previous investigation.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: UNK JUGGERSTITCH
• Type of Device: SOFT-TISSUE/MESH ANCHOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10826798
• MDR Text Key: 215880306
• Report Number: 0001825034-2020-04034
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 20 YR
• Patient Weight: 61