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

Model Number	48361234
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon removed the trial handle to take a couple of x-rays with the trial in the disc space.Upon reinserting/rethreading the trial inserter into the trial, the threaded tip broke off inside of the trial.The surgeon used a curette from the hospital to remove the trial from the disc space and then used a second trial inserter to trial different sizes for the rest of the case.There were no adverse health consequences to the patient.
Event or Problem Description
It was reported that the surgeon removed the trial handle to take a couple of x-rays with the trial in the disc space.Upon reinserting/rethreading the trial inserter into the trial, the threaded tip broke off inside of the trial.The surgeon used a curette from the hospital to remove the trial from the disc space and then used a second trial inserter to trial different sizes for the rest of the case.There were no adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, labelling review, risk assessment.Results: the device was returned for evaluation.The tip of the inserter was found to be fractured off the threading indicating an improper insertion of the tip into the trial.The fractured piece was stuck in the returned trial.No anomalies were found on the trial.No relevant manufacturing issues were identified for the reported lot.Per email correspondence with the rep, there was no cross threading between the trial handle and trial.L5-s1 was the level for this surgery.The angle was not too steep, there was no struggling with inserting the trial or removing the trial.There was no issue with the trial other than the tip of the inserter breaking off inside of it.The ifu indicates that instruments that have experienced extensive use or extensive force are more susceptible to fracture.Conclusion: the age of the device (~10 years) concludes plausible root cause to be due to normal wear based on age and extensive use of the device.

• Brand Name: SLIDE TRIAL HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7560736
• Report Number: 0009617544-2018-00126
• Device Sequence Number: 18876671
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/20/2018

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 Model Number: 48361234
• Device Catalogue Number: 48361234
• Device Lot Number: 088296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1