MAUDE Adverse Event Report: BIOMET TRAUMA PEG SMOOTH 2.0 MM X 16 MM; PLATE, FIXATION

Model Number N/A

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

Patient Problem No Information (3190)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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.

Event Description

It was reported that during a distal volar radius plating procedure, the smooth peg would not lock into the plate.The peg was removed from the patient and surgery was completed with an alternative device.No further patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual analysis of the returned device shows damage to the threads, as well as wear to the head of the pin.The damage to the threads establishes the likelihood that the pin would not have locked into place, and confirms this complaint.The damage prevents any dimensional analysis on the threads.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.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.

• Brand Name: PEG SMOOTH 2.0 MM X 16 MM
• Type of Device: PLATE, 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: 6529375
• MDR Text Key: 73920219
• Report Number: 0001825034-2017-02803
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK111663
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 131212216
• Device Lot Number: 942220
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2016
• 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): Required Intervention