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

Model Number 482397012

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

Event Type  malfunction  

Event 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.

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 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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7150792
• MDR Text Key: 96127112
• Report Number: 0009617544-2017-00445
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 07613327001389
• UDI-Public: (01)07613327001389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 482397012
• Device Catalogue Number: 482397012
• Device Lot Number: 11D124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1