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

Model Number	48280232
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The pharmacist send us a fax and reported that : " during a surgery performed by surgeon relating to an arthrectomy and an arthrodesis in l4-l5 , the spindle broke intra-vertebral" further info is expected.On 06/26/2017 - update / the sales rep sent the intake form filled and provided further info regarding the event as followed : " the neurosurgeon at the hospital reported to our sales rep the following event : " during a percutaneous surgery (herniated disc revision surgery), surgeon used the posterior fixation system.So he used kirschner pins to guide the instrumentation needed to position the pedicle screws.For each screw to position the surgeon has followed the following steps: pedicular screw using a jam shidi / positioning a kirschner pin in the jam shidi / using the dilators / using a tap / positioning the screw.For each screw a new kirschner spindle was used.The event happened before the positioning of the second screw (l4) during the use of the tap.Since the tap had a deviated progression with respect to the axis of the kirschner spindle, the surgeon carried out a scopic check (see photo attached in the intake tab).The picture shows that the pin had broken at the base of the pedicle.The surgeon was able to remove the pin residue left in the pedicle and completed his procedure with a new kirschner spindle." update 06/26/2017 => email received from the sales rep : no patient impact / no medical intervention / no adverse consequences.
Additional Manufacturer Narrative
Manufacturing files were reviewed and no issues were discovered.Tip fracture was confirmed based on visual inspection.The plausible root cause of the reported event is most likely excessive force applied during tapping.
Event or Problem Description
The pharmacist send us a fax and reported that : " during a surgery performed by surgeon relating to an arthrectomy and an arthrodesis in l4-l5, the spindle broke intra-vertebral" further info is expected.On 06/26/2017 - update / the sales rep sent the intake form filled and provided further info regarding the event as followed: "the neurosurgeon at the hospital reported to our sales rep the following event : " during a percutaneous surgery (herniated disc revision surgery), surgeon used the posterior fixation system.So he used kirschner pins to guide the instrumentation needed to position the pedicle screws.For each screw to position the surgeon has followed the following steps: pedicular screw using a jam shidi / positioning a kirschner pin in the jam shidi / using the dilators / using a tap / positioning the screw.For each screw a new kirschner spindle was used.The event happened before the positioning of the second screw (l4) during the use of the tap.Since the tap had a deviated progression with respect to the axis of the kirschner spindle, the surgeon carried out a scopic check (see photo attached in the intake tab).The picture shows that the pin had broken at the base of the pedicle.The surgeon was able to remove the pin residue left in the pedicle and completed his procedure with a new kirschner spindle." update 06/26/2017: email received from the sales rep: no patient impact / no medical intervention / no adverse consequences.

• 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: 6719988
• Report Number: 0009617544-2017-00285
• Device Sequence Number: 772032
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: B78429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1