MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERIARTICULAR DISTAL LATERAL FIBULAR LOCKING PLATE; SCREW, FIXATION

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Current information is insufficient to permit a conclusion as to the cause of the event.Concomitant medical products: zimmer universal 2.7mm locking screw, catalog #: 47482801602, lot #: 63114986; 3.5mm x 14mm self-tapping cortical bone screw, catalog #: 47234801435, lot #: 62933605; 3.5mm x 16mm self-tapping cortical bone screw, catalog #: 47234801635, lot #: 62933610; 3.5mm x 16mm self-tapping cortical bone screw, catalog #: 47234801635, lot #: 63092674; zimmer universal 2.7mm locking screw, catalog #: 47482801202, lot #: 63020095; zimmer universal 2.7mm locking screw, catalog #: 47482801402, lot #: 63048406; zimmer universal 2.7mm locking screw, catalog #: 47482801602, lot #: 63114986.Customer has indicated that the product is in the process of being returned to zimmer biomet for evaluation.Once the evaluation has been completed, a follow-up mdr will be submitted.This report is number 2 of 2 mdr's filed for the same patient (reference 0001822565-2017-02721).

Event Description

It is reported that the patient underwent a removal of a fibular fracture trauma plate approximately eight (8) months post-implantation due to a healed fracture.When the devices were removed, brown matter could be found on the plate and one of the screws.No additional patient consequences were reported.

Manufacturer Narrative

Product has been received by zimmer biomet and the investigation has been completed.Complaint sample was evaluated and the reported event was not confirmed.Device history record 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER PERIARTICULAR DISTAL LATERAL FIBULAR LOCKING PLATE
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6517980
• MDR Text Key: 73566656
• Report Number: 0001822565-2017-02720
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK070906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 47235701804
• Device Lot Number: 61962474
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2012
• 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