MAUDE Adverse Event Report: STRYKER SPINE-US XIA PRECISION JAM SHIDI 10 GAUGE 5 INCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48237105
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; neurosurgeon at the hospital, reported the following event: "the instruments were used to perform a 4 pedicular targetings (levels l4-l5 treated).The 4 targetings were carried out one after the other.For each targeting, the gauge was inserted under scopic control to ensure proper positioning into the pedicle.A hammer was used by the surgeon to advance the needle into the pedicle.The needle has an internal facet stylus that needs to be removed when the needle is correctly positioned.As required by the operative procedure, the surgeon then inserted a nitinol pin into the cannulated needle after removal of the internal stylet.Once the pin was inserted, the needle has been removed from the patient.When surgeon removed the needle from the first pedicle, he noted that 2 "teeth" from the distal end were broken and thus remained in the patient's bone.For the second pedicle, the surgeon used a new gauge.Upon removal, the surgeon again observed that "2 teeth" of the needle were broken.A new gauge was used by the surgeon for the 2 last pedicular shots (the same for both sightings).The rest of the surgery was completed normally." due to this event, there was a delay of about 15 minutes in order to change devices (use of new devices).
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Device was not returned and insufficient information was provided.Conclusion: the root cause could not be determined conclusively.
Event or Problem Description
It was reported that; neurosurgeon at the hospital, reported the following event: "the instruments were used to perform a 4 pedicular targetings (levels l4-l5 treated).The 4 targetings were carried out one after the other.For each targeting, the gauge was inserted under scopic control to ensure proper positioning into the pedicle.A hammer was used by the surgeon to advance the needle into the pedicle.The needle has an internal facet stylus that needs to be removed when the needle is correctly positioned.As required by the operative procedure, the surgeon then inserted a nitinol pin into the cannulated needle after removal of the internal stylet.Once the pin was inserted, the needle has been removed from the patient.When surgeon removed the needle from the first pedicle, he noted that 2 "teeth" from the distal end were broken and thus remained in the patient's bone.For the second pedicle, the surgeon used a new gauge.Upon removal, the surgeon again observed that "2 teeth" of the needle were broken.A new gauge was used by the surgeon for the 2 last pedicular shots (the same for both sightings).The rest of the surgery was completed normally." due to this event, there was a delay of about 15 minutes in order to change devices (use of new devices).

• Brand Name: XIA PRECISION JAM SHIDI 10 GAUGE 5 INCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6166319
• Report Number: 0009617544-2016-00489
• Device Sequence Number: 976151
• Product Code: LXH
• UDI-Device Identifier: 37613327265706
• UDI-Public: (01)37613327265706
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2017

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
• Operator of Device: No Information
• Device Catalogue Number: 48237105
• Device Lot Number: 152925
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1