MAUDE Adverse Event Report: BIOMET TRAUMA FAST 1.1MM DRILLBIT MINIQUICK; PLATE FIXATION

Model Number N/A

Device Problems Fracture (1260); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Synovitis (2094); Foreign Body In Patient (2687)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02247, 0001825034-2017-02249.

Event Description

It was reported that patient¿s right hip was revised approximately 24 years post-implantation due to pain, erosion of the liner, metal-on-metal debris and osteolysis.Operative report noted the presence of metal debris requiring excision of tissues, erosion of the polyethylene liner, loosening of the acetabular cup, and metal synovitis and bone deficiencies in the acetabulum.The acetabular cup, liner and femoral head were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02251.

Event Description

It was reported that during surgery, the drill bit broke off into patient¿s bone.The piece was retrieved.The surgeon continued surgery with another drill bit.That drill bit broke as well.The surgery was completed with another device.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filed to relay that the previous report submitted on april 14, 2017 was submitted erroneously under the wrong manufacturing report number.This event is currently being submitted under 0001825034-2017-03409.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: unk liner, cp153293 univ acet shell 305990, pm150580 5.0 x 95 mm cdh hip knapton 084050.Reported event was confirmed by review of the provided revision op notes.Review of the revision op notes reveal patient underwent a right hip revision procedure approximately 23 years post implantation.Metal debris, femoral head and liner wear, cup loosening and metal synovitis was noted.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.

• Brand Name: FAST 1.1MM DRILLBIT MINIQUICK
• 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: 6443721
• MDR Text Key: 71177835
• Report Number: 0001825034-2017-02250
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• 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: 231220202
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR