MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE AL DISCECTOMY DISTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 48361150

Device Problems Bent (1059); Break (1069); Component Falling (1105); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2017

Event Type  malfunction  

Event Description

It was reported that; during an alif, the distractor was handed to the surgeon.During the instrument handoff, the surgeon noticed there was no tension on the handle of the instrument.He looked down and noticed the handle had separated from the body of the instrument and the corresponding screw and spring fell out of the handle.At the time no one was injured and luckily we had a second distractor as backup so we quickly switched to the back up distractor.Case was then performed flawlessly with no issues.It was apparent that the small pin at the jointed portion of the distractor had broken along with the spring, which caused the issue.This must have happened during sterilization because it was not noticed during case prep or when the instruments were handed off to spd.

Event Description

It was reported that; during an alif, the distractor was handed to the surgeon.During the instrument handoff, the surgeon noticed there was no tension on the handle of the instrument.He looked down and noticed the handle had separated from the body of the instrument and the corresponding screw and spring fell out of the handle.At the time no one was injured and luckily we had a second distractor as backup so we quickly switched to the back up distractor.Case was then performed flawlessly with no issues.It was apparent that the small pin at the jointed portion of the distractor had broken along with the spring, which caused the issue.This must have happened during sterilization because it was not noticed during case prep or when the instruments were handed off to spd.

• Brand Name: RELIANCE AL DISCECTOMY DISTRACTOR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7180823
• MDR Text Key: 97072554
• Report Number: 0009617544-2018-00010
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327268928
• UDI-Public: (01)07613327268928
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48361150
• Device Lot Number: 073942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1