MAUDE Adverse Event Report: STRYKER SPINE-US SPECIALTY CANNULATED PROBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number IS2046XLP

Device Problems Bent (1059); Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  malfunction  

Event Description

It is reported that the cannulated pedicle probe was being used for pedicle access.While malleting it in, it was noticed that the outer sheath of the tip of the probe broke off.The tip must have broke off before entering the pedicle, because it was not stuck in bone and the inner cannula of the probe bent asa result.The surgeon was able to retrieve all pieces once the decompression 2.0 tubes were placed to do the decompression.No adverse consequences to the patient is reported.

Manufacturer Narrative

The reported event was confirmed via correspondence with the sales representative, as well as visual and functional inspection of the returned device.The event resulted in an extended surgery time of 5-15 minutes.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The probe was returned with the inner shaft jammed inside the cannulated probe.Upon inspection of the returned probe, it was confirmed that the inner shaft was bent at the tip which caused it to become jammed inside.The tip of the cannulated probe was found to be fractured.The fractured piece was not returned.Per event description, the fractured tip was noticed while malleting in the probe.Sales rep reported that the tip must have broken off before entering the pedicle, because it was not stuck in bone and the inner cannula of the probe bent as a result.The patient's bone was reported to be harder than average bone which might have resulted in the deformation of the inner shaft tip while malleting in the fractured tip probe.Manufacturing records revealed that the probe was manufactured in 2009.Per email correspondence with sales rep, the probe has previously been used successfully 50-60 times.From instruments general ifu, the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery.The most likely cause of the reported event was determined to be normal wear due to instrument age.

Event Description

It is reported that the cannulated pedicle probe was being used for pedicle access.While malleting it in, it was noticed that the outer sheath of the tip of the probe broke off.The tip must have broke off before entering the pedicle, because it was not stuck in bone and the inner cannula of the probe bent asa result.The surgeon was able to retrieve all pieces once the decompreesion 2.0 tubes were placed to do the decompression.No adverse consequences to the patient is reported.

• Brand Name: SPECIALTY CANNULATED PROBE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7483103
• MDR Text Key: 107340403
• Report Number: 3004024955-2018-00029
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: IS2046XLP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 07/30/2018
• Supplement Dates FDA Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1