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

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the screw was missing when the package was opened.Attempts to obtain additional information have been made; however, no more is available at this time. .

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

• Brand Name: TI LOW PROFILE SCREW 6.5X30MM
• Type of Device: IMPLANT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8115341
• MDR Text Key: 128756951
• Report Number: 0001825034-2018-10935
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K971890
• 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: 01/30/2019

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: 940740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 51