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

Catalog Number	48361235
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon going to remove the trial and inserter the inserter came out without trial attached.It was observed that the threads had broken off the inserter.The second inserter was than used and screwed into the trial and removed successfully without delay or issue.Surgeon believed that he did not fully screw in the inserter upon reattaching it to the trial while in-situ.The surgery was completed successfully with no delay.No patient adverse consequence was reported.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, product history review, complaint history review,nc/capa history review, labelling review, risk assessment.Result: the reported event of was confirmed via correspondence with the sales rep.Tip was confirmed to be fractured upon visual inspection - the tip of the slide trial handle was confirmed to be stuck inside the trial.No relevant manufacturing issues were identified for the reported lot.The instrument ifu indicates that instruments that have experienced extensive use or extensive force are more susceptible to fracture.This device was almost 10 years old at the time of the reported event.Conclusion: the age of the device (~10 years) concludes plausible root cause to be "normal wear based on age and extensive use of the device.".
Event or Problem Description
It was reported that upon going to remove the trial and inserter the inserter came out without trial attached.It was observed that the threads had broken off the inserter.The second inserter was than used and screwed into the trial and removed successfully without delay or issue.Surgeon believed that he did not fully screw in the inserter upon reattaching it to the trial while in-situ.The surgery was completed successfully with no delay.No patient adverse consequence was reported.

• Brand Name: SLIDE RASP HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8093345
• Report Number: 0009617544-2018-00272
• Device Sequence Number: 16445016
• Product Code: LXH
• UDI-Device Identifier: 07613327269116
• UDI-Public: 07613327269116
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/08/2019

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: Health Professional
• Device Catalogue Number: 48361235
• Device Lot Number: 08C701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 12/22/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR