MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.3.5MM SELF DRILLING 12MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48335312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Spinal Cord Injury (2432); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon was undertaking an anterior cervical discectomy and fusion with the intention of implanting a cage and screws.The clinical support specialist was in the case.The surgeon implanted the cage and screws and then decided to move one of the screws.At this point, no x-ray was being used.The surgeon thought he had taken the screw out and handed the screwdriver back to the scrub nurse.The nurse stated that he did not have the screw and the surgeon suggested that he / the scrub team look for the screw.Not realising that the first screw was still in situ, the surgeon then attempted to insert a different screw and found it difficult to insert.The surgeon said that the screw was difficult to insert and asked if there was a tool that could help.The clinical support specialist, also unaware that the screw was still implanted, suggested that a sharp shooter, awl or drill could potentially help.The surgeon then used an awl and a hammer to create a pathway for the second screw.However, this advanced the first screw past the point on the cage where it should stop.He then used a drill which advanced the screw further.He then put in a second screw which pushed the original one into the spinal canal.Once the cage and screws had been implanted, the patient was sent for x-ray and it was only then that the surgeon realised that 2 screws had been implanted, one on top of the other, and thus inserted to a depth which was double that of a single screw.The surgeon then immediately removed the cage and all screws and completed the case using a fresh cage.Post operatively the patient was reported to have some lower leg and upper arm weakness which has been recorded as a spinal cord injury by the hospital.Some recovery is expected but the likely extent of this recovery is currently unclear.
Additional Manufacturer Narrative
Investigation is still underway.Investigation results will be provided once investigation is completed.
Event or Problem Description
It was reported that; the surgeon was undertaking an anterior cervical discectomy and fusion with the intention of implanting a cage and screws.The clinical support specialist was in the case.The surgeon implanted the cage and screws and then decided to move one of the screws.At this point no x-ray was being used.The surgeon thought he had taken the screw out and handed the screwdriver back to the scrub nurse.The nurse stated that he did not have the screw and the surgeon suggested that he/the scrub team look for the screw.Not realising that the first screw was still in situ, the surgeon then attempted to insert a different screw and found it difficult to insert.The surgeon said that the screw was difficult to insert and asked if there was a tool that could help.The clinical support specialist, also unaware that the screw was still implanted, suggested that a sharp shooter, awl or drill could potentially help.The surgeon then used an awl and a hammer to create a pathway for the second screw.However, this advanced the first screw past the point on the cage where it should stop.He then used a drill which advanced the screw further.He then put in a second screw which pushed the original one into the spinal canal.Once the cage and screws had been implanted, the patient was sent for x-ray and it was only then that the surgeon realised that 2 screws had been implanted, one on top of the other, and thus inserted to a depth which was double that of a single screw.The surgeon then immediately removed the cage and all screws and completed the case using a fresh cage.Post operatively the patient was reported to have some lower leg and upper arm weakness which has been recorded as a spinal cord injury by the hospital.Some recovery is expected but the likely extent of this recovery is currently unclear.
Event or Problem Description
It was reported that; the surgeon was undertaking an anterior cervical discectomy and fusion with the intention of implanting a cage and screws.The clinical support specialist was in the case.The surgeon implanted the cage and screws and then decided to move one of the screws.At this point no x-ray was being used.The surgeon thought he had taken the screw out and handed the screwdriver back to the scrub nurse.The nurse stated that he did not have the screw and the surgeon suggested that he / the scrub team look for the screw.Not realising that the first screw was still in situ, the surgeon then attempted to insert a different screw and found it difficult to insert.The surgeon said that the screw was difficult to insert and asked if there was a tool that could help.The clinical support specialist, also unaware that the screw was still implanted, suggested that a sharp shooter, awl or drill could potentially help.The surgeon then used an awl and a hammer to create a pathway for the second screw.However, this advanced the first screw past the point on the cage where it should stop.He then used a drill which advanced the screw further.He then put in a second screw which pushed the original one into the spinal canal.Once the cage and screws had been implanted, the patient was sent for x-ray and it was only then that the surgeon realised that 2 screws had been implanted, one on top of the other, and thus inserted to a depth which was double that of a single screw.The surgeon then immediately removed the cage and all screws and completed the case using a fresh cage.Post operatively the patient was reported to have some lower leg and upper arm weakness which has been recorded as a spinal cord injury by the hospital.Some recovery is expected but the likely extent of this recovery is currently unclear.
Additional Manufacturer Narrative
Method: risk assessment, visual inspection, x-rays analysis.Results: it was reported that two screws has been implanted one on the top of another and thus inserted to a depth which was double that of a single screw.The issue was noticed when the patient was sent for x-rays once the cage and screws had been implanted.The surgeon immediately removed the cage and all screws and completed the case with a new anchor c cage and screws.No issue was reported with the screw.The cage was returned and the screws is locked in the cage.The lot number is not visible for the screw therefore manufacturing history review was not performed.There was no damage the screws identified via visual inspection.Conclusion: the root cause of the reported event is user error.The implant did not malfunction or otherwise fail to perform as intended.It was reported that the surgeon thought he had taken the screw out and handed the screwdriver back to the scrub nurse.The nurse stated that the screw was not handed in with the screwdriver.The surgeon suggested that the scrub team look for the screw and proceeded with implanting the second screw what have resulted in implanting one screw on a top of another.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 12MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 7147504
• Report Number: 3005525032-2017-00115
• Device Sequence Number: 16518277
• Product Code: OVE
• UDI-Device Identifier: 04546540679840
• UDI-Public: (01)04546540679840
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K102606
• 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,Followup
• Report Date (Section B): 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48335312
• Device Catalogue Number: 48335312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 12/02/2017
• Supplement Date Received by Manufacturer: 12/02/2017; 03/21/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 12/27/2017; 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other