MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5MM MULTIDIRECT SCREW 65MM; PLATE, FIXATION

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date explanted - it is unknown if the screw was removed in the (b)(6) 2017 procedure.Concomitant medical product: proximal tibial locking plate, catalog#: 816235807, lot#: ni.The 4.0 mm canc locking screw, catalog#: 816140085, lot#: ni.Cortical screw, catalog#: 815037046, lot#: ni.Multidirect screw, catalog#: 816335065, lot#: ni (qty: 2).The 3.5 mm cort locking screw, catalog#: 816135042, lot#: ni.The 3.5 mm cort locking screw, catalog#: 816135040, lot#: ni.The 3.5 mm cort locking screw, catalog#: 816135050, lot#: ni.The 3.5 mm multidirect screw, catalog#: 816335075, lot#: ni (qty: 2).The 3.5 mm multidirect screw, catalog#: 816335085, lot#: ni.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-05039-1, 0001825034-2017-03672, 03673, 03674, 03677, 03678, 03679, 03680, 10152 and 10157.

Event Description

It was reported that during removal of a right proximal tibial plate approximately twenty-two months post-implantation, it was found that some of the screws were stripped and some of the locking screws were cold welded to the plate.Ultimately, the plate and one screw were left implanted in the patient, as they were unable to complete the removal.

• Brand Name: 3.5MM MULTIDIRECT SCREW 65MM
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7022398
• MDR Text Key: 91770704
• Report Number: 0001825034-2017-10156
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 816335065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention