MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA PRECISION K WIRE BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48230231
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the or manager at the hospital reported to the sales rep the following event : " the event occured during a surgery on l4-l5 on a (b)(6) patient performed.Patient installation and positioning.Preparation of pedicular aiming in l4 and l5 with jam shidi trocar.Insertion of the spindle through the jam shidi trocar.Removal of jam shidi trocars by leaving the pins on the patient.Use the square tip and the tap before installing the screw on the screwdriver and then insert on the patient.When removing the pin from the screw, the surgeon feels a retention of the pin to come out.The x-ray confirms that the spindle is twisted.The surgeon can not remove the patient's spindle alone.Therefore, it removes the screw with the pin.To complete the procedure, the surgeon decides to make a pedicle with the jam shidi trocar again, inserting a new spindle and then inserting the screw.
Additional Manufacturer Narrative
Visual inspection, the k wire was inspected and it was found to be deformed.No relevant manufacturing issues were identified as all units met specifications.The most likely root cause is incorrect alignment or kinking of the k wire inside the screw.
Event or Problem Description
It was reported that; the or manager at the hospital reported to the sales rep the following event : " the event occured during a surgery on l4-l5 on a (b)(6) years-old patient performed.Patient installation and positioning preparation of pedicular aiming in l4 and l5 with jam shidi trocar insertion of the spindle through the jam shidi trocar removal of jam shidi trocars by leaving the pins on the patient use the square tip and the tap before installing the screw on the screwdriver and then insert on the patient.When removing the pin from the screw, the surgeon feels a retention of the pin to come out.The x-ray confirms that the spindle is twisted.The surgeon can not remove the patient's spindle alone.Therefore, it removes the screw with the pin.To complete the procedure, the surgeon decides to make a pedicle with the jam shidi trocar again, inserting a new spindle and then inserting the screw.

• Brand Name: XIA PRECISION K WIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6904736
• Report Number: 0009617544-2017-00368
• Device Sequence Number: 700111
• Product Code: LXH
• UDI-Device Identifier: 07613327265286
• UDI-Public: (01)07613327265286
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: 48230231
• Device Lot Number: 082134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR