MAUDE Adverse Event Report: BIOMET TRAUMA 3.5X30MM CORTICAL SCREW STE; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-05002 / 05003).

Event Description

Patient underwent a plating procedure where a shard of metal was found following the insertion and removal of a screw.The shard was removed and the plate was implanted with other screws.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant devices: distal tibia anterolateral locking plate, catalog #: 856202006 ,lot #: 849970.The product was not returned for review and the complaint was not confirmed.The device history records were reviewed and no discrepancies were found.A review of the complaint history determined that no further action is required.A root cause cannot be determined without physical evaluation of the device.

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a distal tibial plating trauma procedure, following insertion of a non-locking screw, the surgeon lost reduction on the fracture and had to remove the screw.As a result, a shard of metal came out of the plate/screw interface.This screw hole was left empty and other screws were used in the plate to complete the procedure.No foreign parts were left in the patient.

• Brand Name: 3.5X30MM CORTICAL SCREW STE
• Type of Device: PLATE, FIXATION, BONE
• 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: 6142651
• MDR Text Key: 61398661
• Report Number: 0001825034-2016-05002
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• 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: 855037030
• Device Lot Number: DRFBD5 F
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• 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 Outcome(s): Required Intervention