MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
It was reported that during a rotator cuff repair surgery the blue handle of the punch from the speedbridge kit was not working.The handle was not fixed to the metal, so when they tried to remove the punch from bone, only the handle rotated, not the metal part.It was hard for them to remove the punch from the patient.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged ar-2600sbs-5 serial/batch number (b)(6) was received for investigation.Visual evaluation found that the punch shaft is attached to the blue handle.However, it was noted that the part of the shaft that shows off out of the handle is flush with the handle hole.Measurement of the shaft's length failed.Functional tests found that the shaft is attached to the handle and not moving.The most likely cause for the reported failure is the internal manufacturing molding process.The device¿s mold process likely suffered from poor adhesion.

• Brand Name: SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP
• 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: emily shafer ; 8009337001
• MDR Report Key: 17350927
• Report Number: 1220246-2023-07213
• Device Sequence Number: 5290155
• Product Code: MAI
• UDI-Device Identifier: 00888867027329
• UDI-Public: 00888867027329
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP
• Device Catalogue Number: AR-2600SBS-5
• Device Lot Number: 13402081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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
• Patient Sex: Unknown