MAUDE Adverse Event Report: STRYKER SPINE-FRANCE LIGHT CABLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48089999
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; noticed smell coming from light source.When i pulled out light cable notice it was burned.I mediated disconnected and inserted new light cable in new light source unit.
Additional Manufacturer Narrative
Visual analysis, device history review, complaint history review, risk assesment; no manufacturing issues were discovered.All units were designed according to stryker specifications.A picture was provided detailing what light source the hospital used with the cable, however, there was no indication that this hospital owned light source was tested to iec safety standards as indicated in the surgical technique: "light cable must be used with a light source that has been tested to iec safety standards, and is compatible with an acmi connection." the root cause could not be conclusively determined as the light source is not a stryker owned product.
Event or Problem Description
It was reported that; noticed smell coming from light source.When i pulled out light cable notice it was burned.I mediated disconnected and inserted new light cable in new light source unit.

• Brand Name: LIGHT CABLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5769473
• Report Number: 0009617544-2016-00268
• Device Sequence Number: 4474
• Product Code: LXH
• UDI-Device Identifier: 07613327064926
• UDI-Public: (01)07613327064926
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122637
• 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): 06/07/2016

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: 48089999
• Device Lot Number: 154098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1