MAUDE Adverse Event Report: BIOMET TRAUMA DVR PEG SMOOTH 2.0MM X 18MM; APPLIANCE, FIXATION

Model Number N/A

Device Problems Difficult to Insert (1316); Positioning Problem (3009)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown which two pegs were implanted, and which peg was removed and replaced.Concomitant devices ¿ peg smooth 2.0mm x 24mm catalog #: p24000 lot #: ni, peg smooth 2.0mm x 26mm catalog #: p26000 lot #: ni.This report is number 1 of 3 mdrs filed for the same patient (reference 0001825034-2017-04542 / 04543).

Event Description

It is reported that during a distal volar radius trauma fixation procedure, when the surgeon attempted to place a smooth peg into the plate, the peg began to thread, but would not fully seat into the plate.The peg was then reported to be difficult to advance or remove.The surgeon used a multi-directional threaded peg in this peg hole instead.Subsequently, the same occurrence happened on two more peg holes in the plate.The surgeon used a locking tower to help implant these pegs and get them to eventually seat.The process of removing and replacing the smooth pegs added an additional ten (10) minutes to the procedure.No adverse events were reported as a result of the malfunction.

Manufacturer Narrative

This supplemental report is being filed to relay additional information.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: DVR PEG SMOOTH 2.0MM X 18MM
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6692303
• MDR Text Key: 79284670
• Report Number: 0001825034-2017-04541
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050932
• 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,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: P18000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 08/02/2017; 08/31/2017
• Supplement Dates FDA Received: 08/22/2017; 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 57 YR