MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD THORACIC GEARSHIFT; PROBE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.

Event Description

The sales associate reported a probe broke during surgery.The probe snapped off, in the iliac, about 35mm of the distal tip and the tip was unrecoverable.

Manufacturer Narrative

The thoracic gearshift, item # (b)(4), lot # 668540, was returned for evaluation.Visual inspection of the item shows the tip of the probe has fractured off.The fractured tip was not returned with the item.Hardness testing was performed and the results were within specification.The dhr (device history record) was reviewed and no non-conformances are noted.There are no indications of manufacturing issues which would have contributed to this event.The results concluded excessive bending load resulted in the tip fracturing around 35mm mark at transition from circular to rectangular cross section.This is expected area of failure due to transition and resulting stress concentration.The root cause cannot be conclusively determined, but a bending force on the instrument may be a contributing factor.

• Brand Name: THORACIC GEARSHIFT
• Type of Device: PROBE
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5504738
• MDR Text Key: 40487442
• Report Number: 3004485144-2016-00029
• Device Sequence Number: 1
• Product Code: HXB
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NSMD001459
• Device Lot Number: 668540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2014
• 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): Other