MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MEASURING DRILL SLEEVE STE; TRAUMA, INSTRUMENT

Catalog Number 856301005

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the incoming inspection member found a stain on the inner sterile package.There was no patient involvement.

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.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product identified that some of the etch from the product has been transferred on to its tip protector; the item number etching on the product is "816301005" instead of "856301005".The stain on the tip protector is from the laser etching on the product and does not compromise sterility.Device history record was reviewed and no discrepancies were found.The root cause of the reported event can be attributed to the operator error during manufacturing at the supplier.As sterility of the product was not compromised, the medwatch will be moved to not reportable.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.

• Brand Name: MEASURING DRILL SLEEVE STE
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8662534
• MDR Text Key: 146818902
• Report Number: 0001825034-2019-02403
• Device Sequence Number: 1
• Product Code: LXH
• 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
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 856301005
• Device Lot Number: 005830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1