MAUDE Adverse Event Report: PARCUS MEDICAL LLC PROPASS SUTURE PASSER NEEDLE; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Catalog Number	11679
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6)2024 the distributor reported that when performing a shoulder procedure on a male patient of unknown age the propass needle tip broke off in the patient's shoulder.X-ray images indicated that the needle fragment remained in the patient after an attempt was made to remove it.The surgeon reported no current plan to remove the needle fragment.The current status of the patient is unknown.Additional information was solicited.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 25july2024 the distributor reported that when performing a shoulder procedure on a male patient of unknown age the propass needle tip broke off in the patient's shoulder.X-ray images indicated that the needle fragment remained in the patient after an attempt was made to remove it.The surgeon reported no current plan to remove the needle fragment.The current status of the patient is unknown.Additional information was solicited.
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report: the reported event was not confirmed.However the plausible cause was traced to the ifu.A nonconformance was initiated from this complaint to update the product ifu to address hard tissue and or bone when the device is used.A review of the batch record was performed.There was no nonconformance's in the batch record.The product was manufactured to applicable procedures and specifications.A three year retrospective review as performed for the product.There was a previous nonconformance associated to the reported event.The ncr was closed as an isolated incident.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored and trended for future analysis.

• Brand Name: PROPASS SUTURE PASSER NEEDLE
• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): PARCUS MEDICAL LLC; 6423 parkland drive; sarasota FL 34243
• Manufacturer Contact: keith kelly ; 6423 parkland drive; sarasota, FL 34243
• MDR Report Key: 20002097
• Report Number: 3007319107-2024-00011
• Device Sequence Number: 20071913
• Product Code: HCF
• UDI-Device Identifier: 00816342025553
• UDI-Public: (01)00816342025553
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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
• Device Catalogue Number: 11679
• Device Lot Number: 19071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male