MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI-DBLE LEAD CORT 5.0X60MM SCR IA5.0X60MM; ROD, FIXATION

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: ti-dble lead cort 5.0x65mm, scr ia5.0x65mm, catalog: 14-405065, lot 807320; ankle locking nail 11 x 180mm, catalog: 14-440218, lot 528220.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01249.

Event Description

It was reported that during an ankle nailing procedure while attempting to insert a screw after the pilot hole was drilled, the screw would not fully seat.Another screw was tried with the same result.A shorter screw was used to complete the procedure.No additional information is available.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed; visual examination identified damage of the distal threads of the screw and has slivers on the threads coming off of the screw.In the returned condition, the screw would be unable to thread through the nail.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information received.

• Brand Name: TI-DBLE LEAD CORT 5.0X60MM SCR IA5.0X60MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8438151
• MDR Text Key: 139378888
• Report Number: 0001825034-2019-01248
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K063570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-405060
• Device Lot Number: 143980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention