MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48989000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; casper pins were placed in the patient and where a little too close to the endplate, when surgeon went to place the trial it interfered with the pins and subsequently caused bleeding in the patient delaying the case approximately 15 ¿ 20 minutes.Additional conversation with the surgeon concluded that the this was a craftsmanship error by the surgeon and that the placement of the pins were not appropriate for the associated trial.Rep was in the case and confirmed the above situation and that there was no product concern.Rep reported the event as he had the conversation with the surgeon regarding the craftsmanship error causing the bleeding and the delay in surgery.
Additional Manufacturer Narrative
Method: complaint history review, risk assessment.Result: there is no product issue with the trial instrument.Additional conversation with the surgeon concluded that the this was a craftsmanship error by the surgeon and that the placement of the pins were not appropriate for the associated trial.The sales representative attending the case confirmed there was no product concern.This is an isolated event and no other similar events have been reported for this instrument.The reported event resulted in minimal bleeding for the patient.There is no other adverse consequence to the patient.
Event or Problem Description
It was reported that; casper pins were placed in the patient and where a little too close to the endplate, when surgeon went to place the trial it interfered with the pins and subsequently caused bleeding in the patient delaying the case approximately 15 ¿ 20 minutes.Additional conversation with the surgeon concluded that the this was a craftsmanship error by the surgeon and that the placement of the pins were not appropriate for the associated trial.Rep was in the case and confirmed the above situation and that there was no product concern.Rep reported the event as he had the conversation with the surgeon regarding the craftsmanship error causing the bleeding and the delay in surgery.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7096000
• Report Number: 0009617544-2017-00431
• Device Sequence Number: 19128449
• Product Code: LXH
• UDI-Device Identifier: 07613327346671
• UDI-Public: (01)07613327346671
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48989000
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other