MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SPINOUS PROCESS SHORT CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734716
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The spine clamp was returned to medtronic, but analysis has not been completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of procedure.It was reported that there was a box full of damaged instrument.The manufacturing representative stated that some of the tips were visibly bent and the spine clamps would not engage.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of procedure.It was reported that the device was found in a hospital box labeled ¿damaged¿ in the sterile processing department at the facility.The box contained several used instruments.There was no further context able to be provided by the initial reporter.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
The suspect clamp was returned to the manufacturer for evaluation.Visual inspection found that the retainer ring was removed from the adjustment screw.This results in the clamp being able to tighten but not open.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPINOUS PROCESS SHORT CLAMP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8965606
• Report Number: 1723170-2019-04767
• Device Sequence Number: 2521148
• Product Code: OLO
• UDI-Device Identifier: 00643169936294
• UDI-Public: 00643169936294
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2019

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: 9734716
• Device Catalogue Number: 9734716
• Device Lot Number: 160318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 11/15/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/08/2019; 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1