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

Catalog Number	48237105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon at the clinic reported used a jam shidis part number during a percutaneous arthrodesis.Insertion of 4 needles jam shidis into the pedicles of the patient successively.For each needle, radio shots were made throughout the insertion to ensure optimal orientation of the needle into the pedicle.To get the right guidance, the jam shidi needles needed to be move towards the desired direction and assisted by the x-ray control.The needles have an internal stylet facets which is then removed once the needle permanently oriented in the bone tissue.The surgeon then had, according to the operative procedure, to insert the pins into the cannulated needles after the removal of the internal stylus.Once the pins were inserted, the needles were withdrawn one by one from the patient.During the removal of the needles, dr.Observed that one of them had its distal portion where a "teeth" was cut, and therefore remained trapped in the patient's bone.The procedure being performed percutaneously, it was not possible for the surgeon to proceed to the extraction of this little piece of metal.The procedure then continued normally.No adverse consequences, the surgery was completed successfully.
Additional Manufacturer Narrative
Method: risk assessment: result: a lot # could not be obtained, as the device was discarded by the customer, so manufacturing records could not be reviewed.Conclusion: the root cause could not be determined conclusively.
Event or Problem Description
It was reported that; surgeon at the clinic reported used a jam shidis part number during a percutaneous arthrodesis.Insertion of 4 needles jam shidis into the pedicles of the patient successively.For each needle, radio shots were made throughout the insertion to ensure optimal orientation of the needle into the pedicle.To get the right guidance, the jam shidi needles needed to be move towards the desired direction and assisted by the x-ray control.The needles have an internal stylet facets which is then removed once the needle permanently oriented in the bone tissue.The surgeon then had, according to the operative procedure, to insert the pins into the cannulated needles after the removal of the internal stylus.Once the pins were inserted, the needles were withdrawn one by one from the patient.During the removal of the needles, dr.Observed that one of them had its distal portion where a "teeth" was cut, and therefore remained trapped in the patient's bone.The procedure being performed percutaneously, it was not possible for the surgeon to proceed to the extraction of this little piece of metal.The procedure then continued normally.No adverse consequences, the surgery was completed successfully.

• Brand Name: XIA PRECISION JAM SHIDI 10 GAUGE 5 INCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6142627
• Report Number: 0009617544-2016-00481
• Device Sequence Number: 921665
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2017

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1