MAUDE Adverse Event Report: STRYKER SPINE-FRANCE SLIDE TRIAL HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48361234
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the surgeon used a mallet to push the trial in.Upon trying to remove the trial with the slap hammer the trial inserter broke, leaving the threaded portion inside the trial and the trial in the patient.It was removed with a kocher and caused a 5 minute surgery delay; the anchor attached to the white cartridge was loaded backwards.As the surgeon went to put the anchor down the slot he notice the pointed tip was not pointing out.The scrub tech removed the anchor and reloaded it properly.This resulted in a 2 minute surgery delay; one of the screws on the retractor ring came out.It was able to be put in and the ring was able to be locked down.The locking nut on one of the retractor arms is stuck in the locked position.It is unable to be loosened to remove the ring.The ring was disassembled to remove it from the arm.This did not cause a delay in the surgery.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: the slide handle was not returned.No relevant manufacturing issues were found upon dhr review.Conclusion: without the device, the root cause of this event is inconclusive.
Event or Problem Description
It was reported that the surgeon used a mallet to push the trial in.Upon trying to remove the trial with the slap hammer the trial inserter broke, leaving the threaded portion inside the trial and the trial in the patient.It was removed with a kocher and caused a 5 minute surgery delay.The anchor attached to the white cartridge was loaded backwards.As the surgeon went to put the anchor down the slot he notice the pointed tip was not pointing out.The scrub tech removed the anchor and reloaded it properly.This resulted in a 2 minute surgery delay.One of the screws on the retractor ring came out.It was able to be put in and the ring was able to be locked down.The locking nut on one of the retractor arms is stuck in the locked position.It is unable to be loosened to remove the ring.The ring was disassembled to remove it from the arm.This did not cause a delay in the surgery.

• Brand Name: SLIDE TRIAL HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5978438
• Report Number: 0009617544-2016-00377
• Device Sequence Number: 13472932
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2016

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: 48361234
• Device Lot Number: 14C536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2016
• Supplement Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1