MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP CRKSCRW FT VENT 5.5; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP CRKSCRW FT VENT 5.5
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a rotator cuff repair surgery the anchor / screw broke.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint is confirmed.Two unpackaged and two sealed pouches of ar-1927bcf serial/batch number (b)(6).Were received for investigation.Upon visual evaluation of the two open/used devices, no problem was noted with the shaft and handle.However, the two received bios/screws are broken off.Only a small part of each bio was obtained for evaluation.No sharp edges on the shaft¿ tip was found.Visual evaluation of one device of the sealed pouches found no issues with the handle, shaft, sutures, or bios/screws.No sharp edges were observed on the device¿s shaft¿no problems with the bio/screw.The most likely cause for the reported failure is user error for applying excessive force during use.Per dfu-0087.Section e.Warnings.6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.
Event or Problem Description
It was reported that during a rotator cuff repair surgery the anchor / screw broke.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 25-jan-2023.It was confirmed that all broken parts were retrieved from the patient.

• Brand Name: BIO-COMP CRKSCRW FT VENT 5.5
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16329487
• Report Number: 1220246-2023-06243
• Device Sequence Number: 6430680
• Product Code: MAI
• UDI-Device Identifier: 00888867096837
• UDI-Public: 00888867096837
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: BIO-COMP CRKSCRW FT VENT 5.5
• Device Catalogue Number: AR-1927BCFT-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown