MAUDE Adverse Event Report: PARCUS MEDICAL 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHOR

Model Number	10314
Medical Device Problem Codes	Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Inadequate Pain Relief (2388)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon notification of this issue (and two others from the same surgeon - mw5070959 and mw5070960) by letter from the division director of the division of postmarket surveillance at the fda, parcus medical reached out to this surgeon in order to obtain additional information.Per dr.Badia's office, the implantation site was prepared by debridement with shaver and radiofrequency ablation, and the bone quality was reported as "poor".Both of these points are in contradiction to the directions for use that is provided with the implant.This type of anchor is only to be inserted into sites prepared by properly sized drills or awls.Furthermore, the performance of this device is directly related to the quality of bone in which it is inserted.The dfu clearly states this information and therefore no deficiency in the device or labeling provided with this device could be identified.
Event or Problem Description
Per our records, this vigilance was originally submitted on 09/15/2017.However, upon review of the maude database, it was determined that the report was not received by the fda.Therefore, we are resubmitting this report in its entirety as originally reported to the fda.Original submission narrative: patient had an arthroscopic rotator cuff repair on november 3, 2016 in which a parcus medical 45 knotless peek cf push-in suture anchor was implanted.Patient returned to surgeon with complaints of continued pain and limited rom.An mri was conducted and anchor was explanted on (b)(6) 2017.

• Brand Name: 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHOR
• Common Device Name: SUTURE ANCHOR
• Manufacturer (Section D): PARCUS MEDICAL; 6423 parkland drive; sarasota FL 34243
• Manufacturer Contact: paul vagts ; 6423 parkland drive; saraszota, FL 34243 ; 9417557965
• MDR Report Key: 15561774
• Report Number: 3007319107-2017-00001
• Device Sequence Number: 5862237
• Product Code: HWC
• UDI-Device Identifier: M685103140
• UDI-Public: +M685103140/$$32005126246
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2020
• Device Model Number: 10314
• Device Catalogue Number: 10314
• Device Lot Number: 6246
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PARCUS SUTURE TAPE, PART #20042, LOT #16020506
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White