MAUDE Adverse Event Report: STRYKER SPINE-US OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 20; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48558520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; 4.5x20mm non-biased screw broke off just below the head during insertion at l c7.A 2.5 drill was used with the variable drill guide set to 20.The 3.5 tap was used but the surgeon took off the tap sleeve and did not tap to the full depth.The 4.5x20mm non-biased screw was properly loaded onto a t-bar driver and then locked into the power drill.The surgeon then began insertion of the screw into the pedicle.The drill stopped abruptly and it appeared that the battery was dead.We called for another battery and the surgeon decided to use the hand ratchet to finish insertion of the screw.He attempted to hand drive the screw in and when he did the top of the screw (just below the head) broke off.The surgeon called for the screw extraction tray and was finally able to get the bottom of the screw shaft out of the patient after a few attempts.The surgeon made the comment that he feels he may not have tapped deep enough and that the patients bone was very dense.He then asked for another 4.5x20mm non-biased screw and we loaded this screw onto the t-bar driver and placed it on power.The surgeon then began insertion of the second screw into the same trajectory as the first.The screw was almost all the way in and then the driver/screw head started to strip.The surgeon attempted to re tighten the driver connection but was unable to create a secure connection.We then used another t-bar driver but after a failed connection and continued stripping with the other driver as well as a polyaxial screw adjuster he was forced to use a small rod affixed into the head with a set screw and turn the screw the rest of the way in.The surgeon decided to go with 4.0 medial biased screws for the other side of the construct and the rest of the case was finished with no issues.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, labelling review, risk assessment; result: the reported event was confirmed via visual inspection.The polyaxial screw was confirmed to be broken and remained in the tulip.The event resulted in a 25-30 minute delay.Manufacturing records for this product were reviewed and no anomalies were found.The stryker rep reported that the patient had dense bone and that the screw holes were prepared with a 2.5 mm drill and 3.5 mm tap for a 4.5 mm non-biased screw.As per the surgical technique guide "the 4.0mm drill followed by the 4.5mm tap should be used to prepare the pathway for the 4.5mm non-biased angle screws." therefore the probable root cause of the screw fracture was not using the recommended tap size from the surgical technique.
Event or Problem Description
It was reported that; 4.5x20mm non-biased screw broke off just below the head during insertion at l c7.A 2.5 drill was used with the variable drill guide set to 20.The 3.5 tap was used but the surgeon took off the tap sleeve and did not tap to the full depth.The 4.5x20mm non-biased screw was properly loaded onto a t-bar driver and then locked into the power drill.The surgeon then began insertion of the screw into the pedicle.The drill stopped abruptly and it appeared that the battery was dead.We called for another battery and the surgeon decided to use the hand ratchet to finish insertion of the screw.He attempted to hand drive the screw in and when he did the top of the screw (just below the head) broke off.The surgeon called for the screw extraction tray and was finally able to get the bottom of the screw shaft out of the patient after a few attempts.The surgeon made the comment that he feels he may not have tapped deep enough and that the patients bone was very dense.He then asked for another 4.5x20mm non-biased screw and we loaded this screw onto the t-bar driver and placed it on power.The surgeon then began insertion of the second screw into the same trajectory as the first.The screw was almost all the way in and then the driver/screw head started to strip.The surgeon attempted to re tighten the driver connection but was unable to create a secure connection.We then used another t-bar driver but after a failed connection and continued stripping with the other driver as well as a polyaxial screw adjuster he was forced to use a small rod affixed into the head with a set screw and turn the screw the rest of the way in.The surgeon decided to go with 4.0 medial biased screws for the other side of the construct and the rest of the case was finished with no issues.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 20
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7049718
• Report Number: 0009617544-2017-00416
• Device Sequence Number: 16614298
• Product Code: KWP
• UDI-Device Identifier: 04546540596420
• UDI-Public: (01)04546540596420
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: 48558520
• Device Catalogue Number: 48558520
• Device Lot Number: 152010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR