MAUDE Adverse Event Report: SEASPINE INC. BONE PROBE; PROBE-ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number 91-2103

Device Problems Device Operates Differently Than Expected (2913); Naturally Worn (2988)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/10/2015

Event Type  malfunction  

Event Description

It was reported the device was not used in surgery and the device functioned as designed during the last procedure used.

Manufacturer Narrative

It was reported that the probe had faded markings resulting in difficulty to read depth markings and requested replacements.The instrument was received and examined by product and quality engineering and found to have worn and low contrast marking as reported by the distributor, but were legible.Per the information provided, the condition had not been discovered during surgery and there was no patient involvement.Inspection records and drawings specifications are in place to ensure this instrument functions as intended.Per the receiving inspection records-rir, all instruments are 100% visually and functionally inspected and an aql sample inspection is performed on the lot to verify the device meets specification.Additionally, per the rir the qc inspectors will verify supplier certificates of conformance.A dhr review concluded that this instrument was manufactured, inspected and accepted for use by the quality control department, and met all specified of the rir with no associated nonconformance specific to the product issue.A dhr review confirms the instrument passed inspection and released for use over 7 years ago.Since the instrument was in the field for a significant period of time, faded etching can be the result of cleaning technique or consequential handling outside the surgical setting.Based on the available information and evaluation of the device, it appears the root cause of the observed condition was likely due to the fact that the instrument is a re-usable device which experiences repeated cleaning and sterilization cycles that can lead to fading and wear of markings over time.These devices are part of loaner sets that are subject to handling and multiple sterilization cycles after distribution into the field.Wear and damage can occur over time.Therefore no further action will be taken at this time.

• Brand Name: BONE PROBE
• Type of Device: PROBE-ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): SEASPINE INC.; 2302 la mirada dr.; 2302 la mirada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 2302 la mirada dr.; vista CA 92084
• Manufacturer Contact: peter perhach ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165681
• MDR Report Key: 5204292
• MDR Text Key: 30776617
• Report Number: 2032593-2015-00021
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 91-2103
• Device Lot Number: AK58A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2007
• 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