MAUDE Adverse Event Report: PRECISION SPINE, INC BONE PROBE CURVED LENKE; MNH, MNI

Catalog Number PSSPCL

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 02/23/2015

Event Type  Injury  

Event Description

It was reported that during a procedure performed on (b)(6) 2015, while preparing the pedicle, the bone probe (psspcl) stuck in the bone and after numerous attempts to remove it, the tip snapped off.The surgeon had to drill around the tip in order to remove it from the bone with vice grips.It was noted that the patient had extremely hard bone.A delay to the procedure of approximately 10 minutes resulted.

Manufacturer Narrative

Engineer's report states that the tip was broken off in a circumferential manner near the transition of blade geometry to the cylindrical geometry of the shaft.There does not appear to be any indication of a torsional load being applied to the instrument.The fracture does indicate excessive side loading was applied to the instrument that most likely resulted in failure.It should be noted that the broken tip was not returned for examination to determine if any potential stress risers were present at or near the fracture.This instrument has been in service since (b)(6) 2011, so there is a possibility that wear or fatigue contributed to the failure of the instrument.Review of manufacturing history records found a total of forty (40) pieces of this lot were release for distribution on (b)(6) 2011 with no deviation or anomalies.A four-year complaint history review did not find any previous reports of this nature for this part number.As no product non-conformance or a trend for reports of fracture for this part number was identified, the need for corrective action was not indicated.

• Brand Name: BONE PROBE CURVED LENKE
• Type of Device: MNH, MNI
• Manufacturer (Section D): PRECISION SPINE, INC; pearl MS
• Manufacturer Contact: 2050 executive drive; pearl, MS 39208 ; 6014204144
• MDR Report Key: 4741964
• MDR Text Key: 17335959
• Report Number: 3005739886-2015-00042
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K09033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PSSPCL
• Device Lot Number: 527143
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention