MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 PROBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS2739XLP01
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	10/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; attempted to insert the screw after drilling on right pedicle l5.There was found something a metal piece under x ray.There found a fracture piece of by xray.It couldn't be removed out of patient body.Finalized the procedure, but the metal piece remained in the patient body.
Additional Manufacturer Narrative
Lot# 20375; visual inspection; device history review; complaint history review; risk assessment.The device was inspected and it was found that the tip had fractured off.No relevant manufacturing issues were identified as all units met specifications.The most likely cause is wear due to the device's extended use.
Event or Problem Description
It was reported that; attempted to insert the screw after drilling on right pedicle l5.There was found something a metal piece under x ray.There found a fracture piece of by xray.It couldn't be removed out of patient body.Finalized the procedure, but the metal piece remained in the patient body.

• Brand Name: XIA 3 PROBE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6087426
• Report Number: 3004024955-2016-00102
• Device Sequence Number: 704207
• Product Code: LXH
• UDI-Device Identifier: 07613327279313
• UDI-Public: (01)07613327279313
• Combination Product (Y/N): N
• 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): 03/03/2017

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: IS2739XLP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1