MAUDE Adverse Event Report: STRYKER SPINE-US JAM SHIDI, MANTIS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	IS2619MAN
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a small circular piece of metal was noticed in the vertebral body during an interop film.It was determined upon examination that the metal piece may have broken off the distal end of a jam shidi.
Additional Manufacturer Narrative
Review of the manufacturing records did not reveal any relevant manufacturing issues.No manufacturing or material defects were found.It is likely that the reported fracture was due to an applied cantilever load (bending) applied to the instrument and normal wear and tear of instruments.
Event or Problem Description
It was reported that a small circular piece of metal was noticed in the vertebral body during an interop film.It was determined upon examination that the metal piece may have broken off the distal end of a jam shidi.

• Brand Name: JAM SHIDI, MANTIS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5990290
• Report Number: 3004024955-2016-00089
• Device Sequence Number: 13651615
• Product Code: LXH
• UDI-Device Identifier: 07613327279153
• UDI-Public: (01)07613327279153
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2016

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: IS2619MAN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2016
• Supplement Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR