MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO-LL TRIAL, 8MM X 0DEG. - 18MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48940818
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon went to remove the trial it got stuck and the subsequent efforts to remove it resulted in its breakage.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the customer reported event of the device main body fracture was not confirmed.It's confirmed that the threaded end of the reported trial was bent.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event was determined to be cantilever force applied to the trial either during implant size determination or during its removal.
Event or Problem Description
It was reported that when the surgeon went to remove the trial it got stuck and the subsequent efforts to remove it resulted in its breakage.

• Brand Name: AERO-LL TRIAL, 8MM X 0DEG. - 18MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5591261
• Report Number: 0009617544-2016-00157
• Device Sequence Number: 15547
• Product Code: LXH
• UDI-Device Identifier: 07613327273847
• UDI-Public: (01)07613327273847
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/24/2016

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: 48940818
• Device Lot Number: 14G391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2016
• Supplement Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1