MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL SCREW 3.5 X 44MM; PLATE, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Arthritis (1723); Pain (1994); Sepsis (2067); Foreign Body In Patient (2687)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical device lot number - complainant provided a lot number, however, it was discovered to not be valid for this item.Concomitant medical products: cortical screw 3.5 x 60mm catalog# 815037060; cortical screw 3.5 x 50mm catalog# 815037050; fibula comp lock plate 8h catalog# 816204008; 4.0mm canc lock screw 14mm catalog# 816140014; 4.0mm canc lock screw 12mm catalog# 816140012; 4.0mm canc lock screw 24mm catalog# 815037024.User facility has indicated that the product is available for evaluation, however, has not responded to requests of product return.Once the investigation has been completed, a follow-up mdr will be submitted.[(b)(4)].

Event Description

It was reported the patient underwent a subtalar arthrodesis to remove a plate and screws due to experiencing right ankle pain, which was impacting activities of daily living; conservative treatment had been tried with no relief.It was noted that three screws had fractured; the patient retained part of one of the fractured screws.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 was reported.

• Brand Name: CORTICAL SCREW 3.5 X 44MM
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8413842
• MDR Text Key: 138579184
• Report Number: 0001825034-2019-01106
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• 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: 815037044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 63