MAUDE Adverse Event Report: BIOMET TRAUMA 4.0MM CANC LOCK SCREW 44MM; PLATE, FIXATION

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Medical product ¿ cortical screw, catalog#:110017730 lot#: ni; proximal humerus high plate, catalog#: 110030300 lot#: ni; cortical locking screw, catalog#: 816135026 lot#: ni; cortical locking screw, catalog#: 816135028 lot#: ni; cortical locking screw, catalog#: 816135030 lot#: ni; cortical locking screw, catalog#: 816135034 lot#: ni; cortical locking screw, catalog#: 816135038 lot#: ni; cancellous locking screw (qty 2), catalog#: 816140040 lot#: ni; therapy date: jul 28, 2016.

Event Description

During a left proximal humeral plating procedure, upon seating the locking screw under power, a portion of the threads sheared off and fell into the patient's wound.The fractured sliver was removed from the patient.

• Brand Name: 4.0MM CANC LOCK SCREW 44MM
• 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: 6219929
• MDR Text Key: 63773332
• Report Number: 0001825034-2017-00018
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 816140044
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/03/2017
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR