MAUDE Adverse Event Report: STRYKER SPINE-US SPECIALTY DIRECTIONAL JAM SHIDI; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS2511MAN
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the doctor unscrewed the top of the jam shidi and there was a gap (rep was unaware of this).Surgeon malleted down the jam shidi and that is when the tip of the jam shidi broke.The instrument was used once and all broken fragments were retrieved.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: review of the manufacturing records did not reveal any relevant manufacturing issues.Materials analysis was performed previously and fracture mode of ductile overload due to cantilever forces applied to the instrument.No manufacturing or material defects were found.It was reported that the instrument was used 300+ times and that the inner cannula of the instrument was not throughout the inner sleeve which contributed to the tip breaking.Conclusion: the root cause is user misuse of the instrument.
Event or Problem Description
It was reported that; the doctor unscrewed the top of the jam shidi and there was a gap (rep was unaware of this).Surgeon malleted down the jam shidi and that is when the tip of the jam shidi broke.The instrument was used once and all broken fragments were retrieved.

• Brand Name: SPECIALTY DIRECTIONAL JAM SHIDI
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5537882
• Report Number: 3004024955-2016-00038
• Device Sequence Number: 13539974
• Product Code: LXH
• UDI-Device Identifier: 07613327141948
• UDI-Public: (01)07613327141948
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 03/09/2016

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: IS2511MAN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2016
• Supplement Report FDA Received Date: 06/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1