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

Model Number	SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
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 surgery the bone punch of the device loosened when punching the pilot hole.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint is not confirmed.Functional testing between the handle and shaft does not have any issues.However, the disposable punch issue per material report was c0795-01 batch # 15092310, and the returned device was c0795-01 batch # 15064488, which does not belong to ar-2600sbs-5 batch # 15109835, and four swivelocks were not returned from the kit.Laser marks of the returned disposable punch 4.5mm faded, abrasion mark on shaft, and chips on the handle.No problem found.

• Brand Name: SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP
• 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: emily shafer ; 8009337001
• MDR Report Key: 17987291
• Report Number: 1220246-2023-08307
• Device Sequence Number: 15259445
• Product Code: MAI
• UDI-Device Identifier: 00888867027329
• UDI-Public: 00888867027329
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 11/13/2024

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 Model Number: SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP
• Device Catalogue Number: AR-2600SBS-5
• Device Lot Number: 15109835
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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
• Patient Sex: Unknown