MAUDE Adverse Event Report: PRECISION SPINE, INC. BONE PROBE CURVED LENKE; HXB

Catalog Number PSSPCL

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 06/23/2015

Event Type  Injury  

Event Description

It was reported that during a procedure performed (b)(6) 2015 on a patient with very hard bone, the doctor had to strike the bone probe repeatedly with a mallet, resulting in breakage of the tip of the probe.Approximately 20mm of the tip remained in the pedicle.The doctor used a trephine to burr around the tip in order to grab and pull it out.A delay of approximately 40 minutes resulted while a tool was located and sterilized to be used to pull the tip out of the bone.

Manufacturer Narrative

Device evaluation in process.A follow-up report will be submitted upon completion.

Manufacturer Narrative

Engineering review noted the psspcl curved lenke bone probe fractured during the intended use of this instrument.Review of the complaint summary indicates that the bone probe was repeatedly struck with a mallet to advance the probed through very hard bone.The excessive force of impaction was the probable cause of the failure of the tip and can be attributed to misuse.Review of manufacturing history records found a total of five (5) pieces of this lot were released for distribution on april 30, 2008 with no deviation or anomalies.A two-year complaint history review did not identify a trend of misuse for this part number.

Event Description

It was reported that during a procedure performed (b)(6) 2015, on a patient with very hard bone, the doctor had to trike the bone probe repeatedly with a mallet, resulting in breakage of the tip of the probe.Approximately 20mm of the tip remained in the pedicle.The doctor used a trephine to burr around the tip in order to grab and pull it out.A delay of approximately 40 minutes resulted while a tool was located and sterilized to be used to pull the tip out of the bone.

• Brand Name: BONE PROBE CURVED LENKE
• Type of Device: HXB
• Manufacturer (Section D): PRECISION SPINE, INC.; pearl MS
• Manufacturer Contact: 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 4934555
• MDR Text Key: 19001450
• Report Number: 3005739886-2015-00058
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• 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: 590223D08
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2015
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• 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