MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X30MM IA6.5X30MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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 20 mm screw was present in 30 mm package.The procedure was completed with another product.No additional information available.

Event Description

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

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed but the reported event is confirmed based on the lot.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A corrective action has been generated for further investigation into 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.

• Brand Name: TI LOW PROFILE SCREW 6.5X30MM IA6.5X30MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8326110
• MDR Text Key: 137007527
• Report Number: 0001825034-2019-00426
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

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 Model Number: N/A
• Device Catalogue Number: 103533
• Device Lot Number: 859960
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1