MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR CROSSLOCK LOCK STANDARD L; APPLIANCE, FIXATION

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 131227112, lock screw square 2.7mm x 12mm, unknown, 131227110, lock screw square 2.7mm x 10mm, unknown, 131227016, smooth lock peg 2.2mm x 16mm, unknown, 131227016, smooth lock peg 2.2mm x 16mm, unknown, 131227018, smooth lock peg 2.2mm x 18mm, unknown, 131227018, smooth lock peg 2.2mm x 18mm, unknown, 131227022, smooth lock peg 2.2mm x 22mm, unknown, 131227022, smooth lock peg 2.2mm x 22mm, unknown, 131227020, smooth lock peg 2.2mm x 20mm, unknown, 131227020, smooth lock peg 2.2mm x 20mm, unknown, 131227212, lp non lock 2.7mm x 12mm, unknown, 131227210, lp non lock 2.7mm x 10mm, unknown, 131227210, lp non lock 2.7mm x 10mm, unknown.Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Requested but not returned by hospital.

Event Description

It was reported that following a distal volar radius plating procedure, the patient was revised due to pain caused by the plate being placed too distal, which resulted in carpel tunnel.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The reported event could not be confirmed as the visual/dimensional/functional/material evaluation could not be performed, as the reported device was not returned.Photos were provided however, these show cosmetic damage, likely from explantation.Dhr was reviewed and no discrepancies relevant to the reported event were found.Complaint history review determined that no further action(s) is/are required.Without the opportunity to examine the complaint product, a definitive root cause cannot 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: DVR CROSSLOCK LOCK STANDARD L
• Type of Device: APPLIANCE, 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: 7068135
• MDR Text Key: 93243081
• Report Number: 0001825034-2017-10475
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 131822050
• Device Lot Number: SBM065289
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR