MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48480111
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during medical procedure the rod inserter was without function.The distal end of the item loosened from the residue of the instrument.A proper fixation of the rod was not possible anymore.Replacement was available.
Additional Manufacturer Narrative
Visual inspection; functio device history review; complaint history review; risk assessment.The device was returned with the tip fractured off of the device.No relevant manufacturing issues were identified as all units met specifications.The possible root cause of this event is normal wear and tear of the instruments.
Event or Problem Description
It was reported that during medical procedure the rod inserter was without function.The distal end of the item loosened from the residue of the instrument.A proper fixation of the rod was not possible anymore.Replacement was available.

• Brand Name: MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6490353
• Report Number: 0009617544-2017-00149
• Device Sequence Number: 18973414
• Product Code: LXH
• UDI-Device Identifier: 07613327270815
• UDI-Public: (01)07613327270815
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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: 48480111
• Device Lot Number: 11D482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1