MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD SOLITAIRE TI 25MM FISHTAIL DRILL RIGID

Model Number N/A

Device Problems Bent (1059); Break (1069); Fracture (1260); Patient-Device Incompatibility (2682)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/22/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It is reported the surgeon was trying to use the drill to create a path for the screw in the sacrum in an l5-s1 anterior lumbar interbody fusion (alif).The sales associate reports the surgeon mentioned the bone was very hard.He used the 20mm drill and it bent while trying to drill a hole.He then tried the 25mm drill and broke the tip off in the sacrum while trying to create a new path.Finally, he used the awl and was able to create a path and place the screw.He stripped two screws before he was able to finally secure a third screw into the s1.L5 screws were placed without incident.The part and lot numbers of the stripped screws are unknown and they were discarded.It is reported the patient retained a portion of the broken 25mm drill.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Updated based on the device being received for evaluation.

Manufacturer Narrative

The solitaire 25mm fishtail drill, rigid, item # 1400-9213, lot # 019337 was returned for evaluation.Visual inspection of the item shows the tip of the drill has fractured in a manner consistent with excessive torque forces applied to the drill.The missing portion of the drill was not returned.A function check of the returned item cannot be performed because the drilling tip of the device is missing.The length of the device was measured at 10.630¿.The device drawing specifies the length as 11.50¿, indicating approximately 0.870¿ of the drill is missing.Per the complaint, the missing drill tip was retained in the patient, and that the patient had very hard bone.The dhr (device history record) was reviewed; the drills were received and inspected with no non-conformances noted.The hardness measured within the specification for the device.The probable underlying root cause for the damage is excessive torque applied to the drill during use leading to loss of mechanical integrity and ultimately instrument deformation and fracture.Contributing factors include patient condition (hard bone, etc.).

• Brand Name: SOLITAIRE TI 25MM FISHTAIL DRILL RIGID
• Type of Device: DRILL
• 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: 5163307
• MDR Text Key: 28807805
• Report Number: 3004485144-2015-00074
• 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
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• 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: 1400-9213
• Device Lot Number: 019337
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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