MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF GRAFT INSERTION PUSHER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	800307
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; top of plunger broke off.Update 12/19/2017: surgeon prefers to use this instrument with his tlif procedures.Surgeon was not using this instrument with the same brand implant.
Additional Manufacturer Narrative
It was determined that the instrument involved in this event, was manufactured before a design change implementation.In addition, the surgical technique states the following: "while rare, intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, and disposal attention.Instruments must be examined for wear or damage prior to surgery.".
Event or Problem Description
It was reported that; top of plunger broke off.Update 12/19/2017: surgeon prefers to use this instrument with his tlif procedures.Surgeon was not using this instrument with the same brand implant.

• Brand Name: ACCULIF GRAFT INSERTION PUSHER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7150790
• Report Number: 3004024955-2017-00043
• Device Sequence Number: 19298668
• Product Code: LXH
• UDI-Device Identifier: 07613327105919
• UDI-Public: (01)07613327105919
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/21/2018

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 Catalogue Number: 800307
• Device Lot Number: 01201511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1