MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK SCREW SQUARE 2.7MM X 12MM; APPLIANCE, FIXATION

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 12/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation since it was implanted].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a plating procedure a locking screw was not able to be tightened.No additional information was provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Implant date - product was not implanted.Reported event was unable to be confirmed due to limited information received from the customer; visual and dimensional evaluations could not be performed because no product was returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Event Description

It was reported that during an internal fixation procedure of a distal radius fracture, while attempting initial fixation of the plate, a locking screw was not able to be tightened through the oblong hole of the plate; fixation was achieved with other screws through the plate shaft no additional information was provided.

• Brand Name: LOCK SCREW SQUARE 2.7MM X 12MM
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8245601
• MDR Text Key: 132985090
• Report Number: 0001825034-2019-00176
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• PMA/PMN Number: K112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 131227112
• Device Lot Number: UNK.
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1