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

Model Number 48361267

Device Problems Mechanical Problem (1384); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 304445558
• Report Number: 0009617544-2022-00073
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327269468
• UDI-Public: 07613327269468
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1