MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRG IMP SYS W/BIO-COMP SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SPEEDBRG IMP SYS W/BIO-COMP SWVLK
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial rotator cuff suture surgery on (b)(6) 2019 the patient started to experienced major problems (redness, itching and partially open areas) at the operated site.No further information received.Update dw 29-may-2024: the initial surgery was performed on (b)(6) 2019 in ukh klagenfurt and an medical examination will be performed on (b)(6) 2024 in ukh graz.
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.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.
Event or Problem Description
Update dw 06-aug-2024: the customer provided further information that there is no connection between the reported event and the arthrex products.

• Brand Name: SPEEDBRG IMP SYS W/BIO-COMP SWVLK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 19588226
• Report Number: 1220246-2024-06347
• Device Sequence Number: 7326523
• Product Code: MAI
• UDI-Device Identifier: 00888867027312
• UDI-Public: 00888867027312
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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 Expiration Date: 11/30/2020
• Device Model Number: SPEEDBRG IMP SYS W/BIO-COMP SWVLK
• Device Catalogue Number: AR-2600SBS-4
• Device Lot Number: 10259519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2018
• 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