MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS AS SPACER INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48329000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inserter tip broke off.
Additional Manufacturer Narrative
Device inspection, material analysis, device history review, complaint history review, risk assessment.The device was confirmed to have broken locking latch/tip upon visual inspection.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Per material analysis report, the fracture mode wasn't able to be determined due to heavy post fracture damage.The elemental composition was as specified on the print.No material or manufacturing defects were found.It is likely that the tip of the instrument fractured upon excessive impaction force applied, however cannot be determined conclusively.
Event or Problem Description
It was reported that the inserter tip broke off.

• Brand Name: AVS AS SPACER INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6425302
• Report Number: 0009617544-2017-00107
• Device Sequence Number: 19032073
• Product Code: LXH
• UDI-Device Identifier: 07613327267600
• UDI-Public: (01)07613327267600
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/13/2017

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: 48329000
• Device Lot Number: 14D204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1