MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC BROADBAND TAPE; NON ABSORBABLE, UHMWPE SUTURE TAPE

Model Number	CM-0322
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: "it was reported that initial surgery was performed with compre reverse system on (b)(6) 2024.Postoperatively, the patient complained of pain in the shoulder that did not go away.So surgeon checked the x-ray and found that the greater tuberosity fragment that had been sutured at the initial surgery had become free.Pain occurred during elevation movements, and a strange noise occurred during external rotation movements.It is thought that the free bone fragments may be impinging on the implant or in the joint.".
Additional Manufacturer Narrative
The device was not returned.Three retained samples from the same lot were used to perform a knot pull tensile test.The retained samples used for the knot pull tensile test met requirements.Production records were reviewed.There were no nonconformities noted with the lot during production.All finished goods testing requirements were met prior to release.There was no evidence that the device failed to meet specifications, and the report could not be substantiated.A cause for the event cannot be established.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical or its employees that riverpoint medical or its employees have caused or contributed to the event described in this report.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.

• Brand Name: BROADBAND TAPE
• Common Device Name: NON ABSORBABLE, UHMWPE SUTURE TAPE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 19940053
• Report Number: 3006981798-2024-00041
• Device Sequence Number: 7413994
• Product Code: GAT
• UDI-Device Identifier: 00810020081176
• UDI-Public: 00810020081176
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: CM-0322
• Device Lot Number: 23062220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown