MAUDE Adverse Event Report: BIOMET MICROFIXATION BLADE STERNALOCK

Model Number N/A

Device Problems Break (1069); Fracture (1260); Device Or Device Fragments Location Unknown (2590)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.(b)(4).

Event Description

The sales associate reported the tip of the blade broke during surgery.He reported the tip is small therefore it could not be seen on an x-ray scan to determine if it remained inside the patient's body.There was a two hour surgical delay as the surgical room was searched very carefully, however the lost tip of the blade was not found.

Manufacturer Narrative

Updates based on the receipt of the product for evaluation on dec.21, 2015.

Manufacturer Narrative

The product was visually evaluated and confirmed to have the tip fractured.The tip was not returned with the blade.The blade also shows signs of excessive use.The most likely cause of this complaint is excessive use resulting in the damaged blade tip.Ifu states: "surgical instruments are subject to wear with normal usage.Instruments, which have experienced extensive use or excessive force, are susceptible to fracture.Biomet microfixation recommends that all instruments be regularly inspected for wear and disfigurement.".

• Brand Name: BLADE STERNALOCK
• Type of Device: BLADE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5323761
• MDR Text Key: 34263391
• Report Number: 0001032347-2015-00498
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-1194
• Device Lot Number: 217980
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: No
• 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; Other