MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 LE NITINIOL KWIRE BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48280232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the sales representative reported the following event : " in percutaneous surgery, the surgeon, used the fixation system.He used pins to guide the instrumentation needed to position the pedicle screws.For each screw to position the surgeon has followed the following steps: screw pedicle with a jam shidi / positioning a pin in the jam shidi / using the dilators / using a tap / positioning the screw.For each screw a new spindle was used.The event occurred before the 4th and last screw was positioned.When the surgeon used the tap, he realized that the tap had no grip in the patient's bone.A x-ray shot was thus performed, which showed that the pin had bent at its base (forming a "z").Since this curvature did not allow the tap to progress along the pin, the surgeon repeatedly tried to remove this pin from the patient's vertebra (by pulling it).With the pin blocked in the vertebra, surgeon attempted to slide a jam shidi along this pin to facilitate its removal.Once the jam shidi was positioned, the surgeon again attempted to pull the pin repeatedly.Once removed the surgeon realized that the pin was broken and that a piece had remained stuck in the patient's pedicle.A xray control confirmed the presence of the pin residue in the pedicle.This residue could not be removed from the patient.On 05/10/2017 => information update provided by the sales rep : " no patient impact - no medical intervention - lot number still unknown (waiting for the return of the device) - device available : transportation organized by the sales rep).
Additional Manufacturer Narrative
The device was not returned and a valid lot number was not provided therefore manufacturing history could not be reviewed.Due to the device not being returned, a definite root cause cannot be determined.
Event or Problem Description
It was reported that: the sales representative reported the following event : " in percutaneous surgery, the surgeon, used the fixation system.He used pins to guide the instrumentation needed to position the pedicle screws.For each screw to position the surgeon has followed the following steps: screw pedicle with a jam shidi / positioning a pin in the jam shidi / using the dilators / using a tap / positioning the screw.For each screw a new spindle was used.The event occurred before the 4th and last screw was positioned.When the surgeon used the tap, he realized that the tap had no grip in the patient's bone.A x-ray shot was thus performed, which showed that the pin had bent at its base ).Since this curvature did not allow the tap to progress along the pin, the surgeon repeatedly tried to remove this pin from the patient's vertebra (by pulling it).With the pin blocked in the vertebra, surgeon attempted to slide a jam shidi along this pin to facilitate its removal.Once the jam shidi was positioned, the surgeon again attempted to pull the pin repeatedly.Once removed the surgeon realized that the pin was broken and that a piece had remained stuck in the patient's pedicle.A xray control confirmed the presence of the pin residue in the pedicle.This residue could not be removed from the patient.On 05/10/2017: information update provided by the sales rep : "no patient impact - no medical intervention - lot number still unknown (waiting for the return of the device) - device available: transportation organized by the sales rep).

• Brand Name: ES2 LE NITINIOL KWIRE 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: 6595304
• Report Number: 0009617544-2017-00226
• Device Sequence Number: 13625104
• Product Code: LXH
• UDI-Device Identifier: 07613327096200
• UDI-Public: (01)07613327096200
• 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): 10/16/2017

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 Model Number: 48280232
• Device Catalogue Number: 48280232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 52