MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA II PA ADUSTMENT DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48047033
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that;the regional sales manager spine reported the following event : " during a procedure related to an extraction of 8 screws on a (b)(6) patient, the neurosurgeon thought he could perform the surgery with the ablation kit made by the sales rep in 2016 (the kit was delivered in october 2016).Dr first tried the screwdriver in the box (first generation ) and then opening the but to no avail.The only ancillary device that removes the screws correctly is the internal screwdriver rod , which was not placed in the ablation kit.Dr succeeded in removing 2 screws with gouge forceps but the surgeon decided to stop the surgery because it was too complicated and risky for the patient (according to the operating room (or) manger at the hospital who phoned ).So dr did not complete the surgery successfully and planned to revise the patient next week (tuesday (b)(6)).Asked to (b)(6) to have an ablation kit sent urgently to make sure that the removal of the last 6 screws will be removed serenely during the next surgery.".
Additional Manufacturer Narrative
The reason for the extraction surgery is the consolidation of the spine.As the patient is young, the surgeon decided to extract the screws.Investigation results: based on the reported event, where a custom kit did not contain the correct instrument required for the revision surgery, it has been determined that this event was not related to the design or manufacturing process.It was determined that the sales representative created a custom-made kit with incorrect part references in it and the correct screwdriver required to remove the screw, was not provided in the kit.The cause of the reported event is a human error.This event is an isolated incident and there have been no reports of similar events.The instructions for use state "instruments must be examined for wear or damage prior to surgery." in addition, the screw's surgical technique lists that another screwdriver can be used to remove the screws.The reported screwdriver is not the only screwdriver that can to be used to remove the reported screws.
Event or Problem Description
It was reported that;the regional sales manager spine reported the following event : " during a procedure related to an extraction of 8 screws on a (b)(6) patient, the neurosurgeon thought he could perform the surgery with the ablation kit made by the sales rep in 2016 (the kit was delivered in (b)(6) 2016).Dr first tried the screwdriver in the box (first generation ) and then opening the but to no avail.The only ancillary device that removes the screws correctly is the internal screwdriver rod , which was not placed in the ablation kit.Dr succeeded in removing 2 screws with gouge forceps but the surgeon decided to stop the surgery because it was too complicated and risky for the patient (according to the or manger at the hospital who phoned ).So dr did not complete the surgery successfully and planned to revise the patient next week (tuesday (b)(6)).Asked to france to have an ablation kit sent urgently to make sure that the removal of the last 6 screws will be removed serenely during the next surgery.".

• Brand Name: XIA II PA ADUSTMENT DRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6763169
• Report Number: 0009617544-2017-00300
• Device Sequence Number: 11249696
• Product Code: LXH
• UDI-Device Identifier: 07613327263312
• UDI-Public: (01)07613327263312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 48047033
• Device Catalogue Number: 48047033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 02/05/2018
• 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: Required Intervention
• Patient Age: 18 YR