MAUDE Adverse Event Report: ARTHREX, INC. CURVED SPEAR, FIBERTAK, REUSABLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CURVED SPEAR, FIBERTAK, REUSABLE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/17/2023, it was reported by a sales representative via (b)(4) that an ar-3610ctc curved fibertaks drill guide was bent.This occurred during a procedure; the 1.8 knotless fibertak was inserted in a standard fashion using the reusable curved drill guide.After the insertion of the anchor, the guide was removed, and it was noticed that one of the tips on the crown of the guide was bent.This was not noticeable at the beginning of the case.There was no additional information provided, and additional information has been requested.
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: d9, g3, h6.The complaint allegation was confirmed.One unpackaged ar-3610ctc serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the device tip being bent.Upon evaluating the device, it was noted that one of the crown edges was bent.The observed condition is most likely the result of interference between the device and other instrumentation during use.

• Brand Name: CURVED SPEAR, FIBERTAK, REUSABLE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 18113199
• Report Number: 1220246-2023-08687
• Device Sequence Number: 15371323
• Product Code: LXH
• UDI-Device Identifier: 00888867354265
• UDI-Public: 00888867354265
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: CURVED SPEAR, FIBERTAK, REUSABLE
• Device Catalogue Number: AR-3610CTC
• Device Lot Number: 0072302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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