MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH; TRAUMA, INSTRUMENT

Catalog Number 47249009700

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05980, 0001822565-2018-05981, 0001822565-2018-05983, 0001822565-2018-05985, 0001822565-2018-05986, 0001822565-2018-05988, 0001822565-2018-05989, 0001822565-2018-05990, 0001822565-2018-05992, 0001822565-2018-05993, 0001822565-2018-05995, 0001822565-2018-05996, 0001822565-2018-05998, 0001822565-2018-05999, 0001822565-2018-06001, 0001822565-2018-06002, 0001822565-2018-06003, 0001822565-2018-06004, 0001822565-2018-06006, 0001822565-2018-06008, 0001822565-2018-06010, 0001822565-2018-06011, 0001822565-2018-06012, 0001822565-2018-06014, 0001822565-2018-06015.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.Product not returned.

Event Description

It was reported that a crease was found in the sealing area during incoming inspection.There was no patient involvement.

Event Description

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

Manufacturer Narrative

Report source foreign - (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned products identified that 13 pieces from lot # 64053676, 11 were found conforming and two pieces failed.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency.Corrective actions have been initiated to address this issue.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Results - 111 was incorrectly reported and needs removed.Conclusion - 23 was incorrectly reported and needs removed.There was no issue found with the product.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.If any further information is found which would change or alter anyd conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8027409
• MDR Text Key: 125759494
• Report Number: 0001822565-2018-05980
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 47249009700
• Device Lot Number: 64021728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0542-2019
• Patient Sequence Number: 1