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

Catalog Number	48361150
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7180823
• Report Number: 0009617544-2018-00010
• Device Sequence Number: 96477
• Product Code: LXH
• UDI-Device Identifier: 07613327268928
• UDI-Public: (01)07613327268928
• Combination Product (Y/N): N
• 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): 03/29/2018

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: 48361150
• Device Lot Number: 073942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1