MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK SMOOTH PEG 2.2MM 18MM STE; APPLIANCE, FIXATION

Catalog Number 131827018

Device Problem Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot number: 256280, 551020.Expiration date: lot 256280- jun 29, 2028, lot 551020- jul 31, 2028.Udi#: (b)(4).Concomitant medical products: 131821041 dvr lock narrow mini l st 505940.Foreign- (b)(6).Lot 256280- jun 29, 2018, lot 551020- jul 31, 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is not sure which screw had malfunctioned, hence both the screws with different lot# and same part# are being reported.

Event Description

It was reported that initial dvr crosslock plate procedure was performed.During regular checkup, it was detected that the screw was completely backed out.A revision procedure was performed seven (7) months post primary implantation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of pictures and radiographs.Photographs of the cross lock plate and an explanted screw were provided.Visual review identified scratches on the cross lock plate.No other damages were observed and no further evaluation could be performed with the photograph provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: interval disassociation of the distal screw from the metallic side plate of the distal radius.No other observations related to the event were noted.Device history record (dhr) was reviewed and no discrepancies 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.

Event Description

No additional event information is available at the time of this report.

• Brand Name: LOCK SMOOTH PEG 2.2MM 18MM STE
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9928153
• MDR Text Key: 190014664
• Report Number: 0001825034-2020-01432
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• PMA/PMN Number: K132704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 131827018
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention