MAUDE Adverse Event Report: STRYKER SPINE-FRANCE PEDICLE BASE RETRACTOR MEDIAL ARM ASSEMBLY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48760631C
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, " the surgeon put 4 pedicle screws and one cage.When opening the boxes of the device, the medial arm of the spreader was broken in the piston central level which unable the full withdrawal of the blade.When using the spreader, facing the impossibility to separate the two blades clipped based on the retractor, the surgeon had to remove the patient's stent, remove the silicone blade, then make so that the screw serving to deviate is engaged again with its base to actuate the wedge mechanism.This manually separating the blades as he insisted that the screw is engaged with the base.
Additional Manufacturer Narrative
Catalog# 48760631c, lot# 155340.Results pending investigation closure.Results will provided in additional supplemental.
Event or Problem Description
It was reported that, " the surgeon put 4 pedicle screws and one cage.When opening the boxes of the device, the medial arm of the spreader was broken in the piston central level which unabled the full withdrawal of the blade.When using the spreader, facing the impossibility to separate the two blades clipped based on the retractor, the surgeon had to remove the patient's stent, remove the silicone blade, then make so that the screw serving to deviate is engaged again with its base to actuate the wedge mechanism.This manually separating the blades as he insisted that the screw is engaged with the base.
Additional Manufacturer Narrative
Lot# 155340.Method: visual inspection; material analysis; device history review; complaint history review; risk assessment.Results: a material analysis was performed and it was found that the device fracture in ductile overload and that the material of the screw was to spec.No relevant manufacturing issues were identified as all units met specifications.Conclusion: the root cause of the event was most likely the screw was overtorqued by the user, as no issue was found with the material of the device.
Event or Problem Description
It was reported that, the surgeon put 4 pedicle screws and one cage.When opening the boxes of the device, the medial arm of the spreader was broken in the piston central level which enabled the full withdrawal of the blade.When using the spreader, facing the impossibility to separate the two blades clipped based on the retractor, the surgeon had to remove the patient's stent, remove the silicone blade, then make so that the screw serving to deviate is engaged again with its base to actuate the wedge mechanism.This manually separating the blades as he insisted that the screw is engaged with the base.

• Brand Name: PEDICLE BASE RETRACTOR MEDIAL ARM ASSEMBLY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5679944
• Report Number: 0009617544-2016-00206
• Device Sequence Number: 171406
• Product Code: LXH
• UDI-Device Identifier: 07613327266061
• UDI-Public: (01)07613327266061
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2016

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 Catalogue Number: 48760631C
• Device Lot Number: 155340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 09/15/2016; 10/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1