MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C SCREW EXTRACTOR DRAW ROD REPLACEMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328625AR
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon attempted to remove a screw from a cage that was implanted.He used a removal driver that comes in the set but was unable to get the screwdriver to connect into the screw with the draw rod.He left the screw in place and did not attempt to remove it again.He then noticed that the tip of the draw rod was broken off and he said it was stuck in the screw.The surgeon was not worried about it coming out and closed the patient.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: device was not returned.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the plausible root cause of the reported event is not determined.
Event or Problem Description
It was reported that the surgeon attempted to remove a screw from a cage that was implanted.He used a removal driver that comes in the set but was unable to get the screwdriver to connect into the screw with the draw rod.He left the screw in place and did not attempt to remove it again.He then noticed that the tip of the draw rod was broken off and he said it was stuck in the screw.The surgeon was not worried about it coming out and closed the patient.

• Brand Name: ANCHOR C SCREW EXTRACTOR DRAW ROD REPLACEMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5419795
• Report Number: 0009617544-2016-00051
• Device Sequence Number: 282196
• Product Code: LXH
• UDI-Device Identifier: 07613327276848
• UDI-Public: 07613327276848
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/15/2016

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: 48328625AR
• Device Lot Number: 127908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2016
• Supplement Report FDA Received Date: 04/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1