MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 POWER ADAPTOR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482397012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; while loading a tap into the power adapter, one of the tabs broke off.The power adapter was still usable and we finished the case with no issues.
Additional Manufacturer Narrative
Risk assessment; the reported event was confirmed via correspondence.It was reported that while loading a tap into the power adapter, one of the taps broke off.The power adapter was still usable and used to finish the case with no issues.Since the adaptor was still usable, there was most likely no issue with the power adaptor.Visual, dimensional and functional analysis could not be performed as the device was not returned.The device was unable to be located in the field.Manufacturing history was reviewed and no relevant manufacturing issues were identified.The most likely root cause was the using a power adaptor with a tap which is recommended against in the surgical technique.According to the surgical technique, "to prepare the hole for screw insertion, only manual tapping is recommended.Tapping with power has not been assessed for safety and accuracy.".
Event or Problem Description
It was reported that; while loading a tap into the power adapter, one of the tabs broke off.The power adapter was still usable and we finished the case with no issues.

• Brand Name: XIA 3 POWER ADAPTOR
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7150792
• Report Number: 0009617544-2017-00445
• Device Sequence Number: 738555
• Product Code: MNH
• UDI-Device Identifier: 07613327001389
• UDI-Public: (01)07613327001389
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120434
• 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): 03/15/2018

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: 482397012
• Device Catalogue Number: 482397012
• Device Lot Number: 11D124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1