MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR CROSSLOCK NARROW MINI L; PLATE, FIXATION

Model Number N/A

Device Problems Difficult to Insert (1316); Migration (4003)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 07/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - unknown trauma screw.Report source, foreign ¿ events occurred in (b)(6).Product is currently not expected to return to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.Multiple mdr reports were filed for this event, please see all associated reports: 0001825034-2018-08421, 0001825034-2018-08432.

Event Description

It was reported that during the implantation of a trauma plate, the surgeon had difficulty inserting the locking screws, as they were not locking correctly in the plate.Approximately two (2) weeks after the procedure, a radiograph revealed that a screw had backed out.It is not known at this time if this screw has been explanted.

Manufacturer Narrative

An x-ray was received and reviewed.Per the review, "a screw within the distal radius appears to have backed out volarly with punctate metallic densities seen within the soft tissue overlying this region." reported event was confirmed by review of x-rays provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause could not be determined; however, it is noted that the patient has had previous fractures, poor bone quality, and high bmi which may have contributed to the reported event.A summary of the investigation has been sent to the complainant.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.

Event Description

No further event information available at the time of this report.

• Brand Name: DVR CROSSLOCK NARROW MINI L
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7808548
• MDR Text Key: 117973723
• Report Number: 0001825034-2018-08421
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• 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: 131821040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR