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Model Number 9733856
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2022
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products:other relevant device(s) are: product id: unknown, navigation component, lot/serial #: unknown. Patient age is the mean value of patients in the study. Patient gender is the majority value of patient in the study. Patient weight not available from the site. Event date is the online publishing date of the literature article. Device lot number, or serial number, unavailable. 510(k) is dependent upon the device model number and therefore, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Event Description
Pan, h. K. , liuid, c. W. , pan, r. Y. Comparison of suture anchor penetration rate between navigation-assisted and traditional shoulder arthroscopic capsulolabral repair. Plos one. 2022. 17(1-9) https://doi. Org/10. 1371/journal. Pone. 0267943 proper placement of suture anchors is an important step in bankart repair as improper placement can lead to failure. Concern surrounding suture anchor placement inspired the use navigation systems in shoulder arthroscopy. We aimed to demonstrate the technological advantage of using the o-arm (medtronic navigation, denver, co, usa) image guidance system to provide real-time images during portal and anchor placements in shoulder arthroscopy. Consecutive patients (from july to october 2014) who were admitted for arthroscopic capsulolabral repair surgeries were included. Ten patients were randomly enrolled in the navigation group and 10 in the traditional group. The glenoid was divided into four zones, and the penetration rates in each zone were compared between the two groups. In zone iii, the most inferior region of the glenoid, the penetration rate was 40. 9% in the traditional group and 15. 7% in the navigation group (p
0. 077), demonstrating a trend toward improved accuracy of anchor placement with the aid of the navigation system; however, this was not statistically significant. Average surgical time in the navigation and traditional groups was 177. 6±40. 2 and 117. 7±17. 6 mins, respectively. American shoulder and elbow surgeons shoulder scores showed no difference before and 6 months after surgery. This pilot study showed a trend toward decreased penetration rate in o-arm-navigated capsulolabral repair surgeries and decreased risks of implant misplacement; however, possibly due to the small sample size, the difference was not statistically significant. Further large-scale studies are needed to confirm the possible benefit of the navigation system. Even with the use of navigation systems, there were still some penetrations in zone iii of the glenoid. This penetration may be attributed to the micro-motion of the acromioclavicular joint. Although the navigation group showed a significant increase in surgical time, with improvements in instrument design, o-arm-navigated arthroscopy will gain popularity in clinical practice. Reported events reference frameshift during navigation.
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Manufacturer (Section D)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key14720420
MDR Text Key303151032
Report Number1723170-2022-00924
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown