MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BEAD TIP GD WIRE 2.6MM X 80CM; PIN, FIXATION

Catalog Number 14-410002

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign - (b)(4).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.

Event Description

It was reported that when the product was received the external box and the sterile packaging was open.There was no surgical involvement.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: BEAD TIP GD WIRE 2.6MM X 80CM
• Type of Device: PIN, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11789996
• MDR Text Key: 249456864
• Report Number: 0001825034-2021-01337
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 0088786809298
• UDI-Public: (01)0088786809298(17)300821(10)312770
• Combination Product (y/n): N
• PMA/PMN Number: K831005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-410002
• Device Lot Number: 312770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1