MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS M A ADJUSTMENT TOOL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	486619100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon was removing a pedicle screw and the tip of the driver broke off during a revision update (b)(6) 2016: revision surgery was to remove the screws at l4-s.There was a broken screw at s1.Then tlif l3-l4.The.Reinsert screws from l3-s1 using competitor's screws.
Additional Manufacturer Narrative
Lot# 07g515.Method: visual analysis, device history review, complaint history review, risk assesment; result: upon visual inspection, all four prongs at the distal end of the adjustment tool were fractured, confirming the reported event.No other issues were discovered.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The age of the device may have also contributed to the fracture.The device has been in the field for roughly 9 years.Consistent use of the device over time may lead to breakage of the instrument.This is also further confirmed in the ifu, which states "instruments which have experienced extensive use or extensive force are more susceptible to fracture." conclusion: a plausible root cause is user error and/or device age (~9 years).
Event or Problem Description
It was reported that; surgeon was removing a pedicle screw and the tip of the driver broke off during a revision.Update 6/22/2016: revision surgery was to remove the screws at l4-s.There was a broken screw at s1.Then tlif l3-l4.The.Reinsert screws from l3-s1 using competitor's screws.

• Brand Name: RADIUS M A ADJUSTMENT TOOL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5780594
• Report Number: 0009617544-2016-00276
• Device Sequence Number: 201126
• Product Code: LXH
• UDI-Device Identifier: 07613327276053
• UDI-Public: (01)07613327276053
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/14/2016

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: 486619100
• Device Lot Number: 07G515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1