MAUDE Adverse Event Report: STRYKER SPINE-FRANCE SLIDE INTEGRATED DISTRACTOR INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48361220
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when threading the t handle is almost completely down.The threads were jumping therefore not advancing the implant.I wasn't advancing while inserting the implant.
Additional Manufacturer Narrative
Lot# 07e999.Method: visual inspection, functional analysis, device history review, complaint history review, risk assessment; result: the device was returned and device evaluation was performed.The reported product issue could not be confirmed since no visual or functional anomalies were found.Device was found to be functional.No relevant manufacturing issues were found.Conclusion: the exact root cause could not be determined conclusively.
Event or Problem Description
It was reported that; when threading the t handle is almost completely down.The threads were jumping therefore not advancing the implant.I wasn't advancing while inserting the implant.

• Brand Name: SLIDE INTEGRATED DISTRACTOR 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: 6518664
• Report Number: 0009617544-2017-00168
• Device Sequence Number: 10984301
• Product Code: LXH
• UDI-Device Identifier: 07613327269062
• UDI-Public: (01)07613327269062
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/19/2017

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: 48361220
• Device Lot Number: 07E999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1