MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS 3.5X12MM CORTICAL LOCK SCREW STE; PLATE, FIXATION

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign- (b)(6).Concomitant medical products-fib anatomic lock rt 3h ste catalog#:856207003 lot#:245720.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 is reported that during a distal fibula plating procedure, the screw couldn't be fixed into the plate, as it continued to rotate.The screw was removed, and the surgeon finished the surgery successfully with an alternative screw.No additional patient consequences were reported.

Manufacturer Narrative

Udi# (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product noted damaged of the threads on the head of the screw.Dhr was reviewed and no discrepancies relevant to the reported event 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: ALPS 3.5X12MM CORTICAL LOCK SCREW STE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7779532
• MDR Text Key: 117000140
• Report Number: 0001825034-2018-08105
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK111663
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• 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: 856135012
• Device Lot Number: 805140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention