MAUDE Adverse Event Report: STRYKER SPINE-US SLIDE RASP 22 X 28MM 16MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48361267
Medical Device Problem Codes	Mechanical Problem (1384); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a reliance slide rasp handle tip broke off within a reliance slide rasp trial intra-operatively.The rasp was successfully removed, an alternate device was used and surgery was completed successfully.No adverse consequences, surgical delay or medical intervention were reported.This report captures the trial.
Additional Manufacturer Narrative
B5 was corrected.There was no issue reported with the rasp.The device was returned and no issue was identified via visual inspection therefore this device is concomitant.H6 coding has been updated to reflect device evaluation and investigation conclusion.
Event or Problem Description
It was reported that the rasp handle tip broke off within a rasp.The patient was unaffected and the procedure was completed successfully.There was no issue reported with the rasp.The device was returned and no issue was identified via visual inspection therefore this device is concomitant.This report captures the trial.

• Brand Name: SLIDE RASP 22 X 28MM 16MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15053527
• Report Number: 0009617544-2022-00073
• Device Sequence Number: 17339532
• Product Code: LXH
• UDI-Device Identifier: 07613327269468
• UDI-Public: 07613327269468
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/11/2022

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 Model Number: 48361267
• Device Catalogue Number: 48361267
• Device Lot Number: 084523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown