MAUDE Adverse Event Report: BIOMET TRAUMA 1ST MTP FUSION PLT LT; PLATE, FIXATION

Catalog Number 824071001

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 during a left 1st metatarsophalangeal (mtp) arthrodesis, the guide stuck to the plate and would not detach, causing the need to remove the fusion plate from the patient's wound.Another plate was used to complete the procedure with minimal delay.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.An additional supplemental will be created when the product evaluation is completed.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection shows slight wear marks on one of the f.A.S.T.Guides assembled to the plate.Functional testing was performed, attempting to remove the f.A.S.T guides from the plate using the applicable handle and driver.All guides were able to be removed except the guide with the visible damage.The driver appeared to slip in the guide when torque was applied, indicating the guide was stripped.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Dhr was reviewed and no discrepancies relevant to the reported event were found.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: 1ST MTP FUSION PLT LT
• 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: 6404279
• MDR Text Key: 69945479
• Report Number: 0001825034-2017-01571
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 824071001
• Device Lot Number: SBM072497
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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
• Treatment: UNK FAST GUIDE, CAT#: NI LOT#: NI
• Patient Outcome(s): Required Intervention