MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SMOOTH GUIDE WIRE BALL TIP 3.0 MM DIAMETER 100 CM; INSTRUMENT, EXTREMITIES

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

(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 upon receipt visual inspection found the guide wire protruded through the sterile packaging and is no longer sterile.Sales rep indicates no additional information is available.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event can be attributed to transit damage.Visual examination of the returned product/provided pictures found the outer carton is damaged and the product has punctured through the sterile packaging.Sterility has been breached.The condition of the device when it left zimmer biomet is conforming to specification.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: SMOOTH GUIDE WIRE BALL TIP 3.0 MM DIAMETER 100 CM
• Type of Device: INSTRUMENT, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11605672
• MDR Text Key: 243574760
• Report Number: 0001822565-2021-00911
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024581845
• UDI-Public: (01)00889024581845(17)240531(10)64386045
• Combination Product (y/n): N
• PMA/PMN Number: K191238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 47225500801
• Device Lot Number: 64386045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1