MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL INSERTER GUIDE INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48921100
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the inserter guide inner shaft broke after malleting the cage into the disc space.Plate was used since the inserter was not attached to deliver the anchors.
Additional Manufacturer Narrative
Method: risk assessment.Results: no lot # was provided, so a manufacturing record review could not be performed.Visual, dimensional and functional analysis could not be performed as the device was not returned.Conclusion: since the device was not returned, the root cause cannot be determined.
Event or Problem Description
It was reported that; the inserter guide inner shaft broke after malleting the cage into the disc space.Plate was used since the inserter was not attached to deliver the anchors.

• Brand Name: AERO AL INSERTER GUIDE INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6553730
• Report Number: 0009617544-2017-00186
• Device Sequence Number: 808364
• Product Code: LXH
• UDI-Device Identifier: 07613327273496
• UDI-Public: (01)07613327273496
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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 Model Number: 48921100
• Device Catalogue Number: 48921100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1