MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER,5.5MM X 13CM; SAW BLADE

Model Number	BONE CUTTER,5.5MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
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
On (b)(6) 2023, it was reported by a sales rep via email that an ar-8550bc, bone cutter,5.5mm x 13cm is shedding iron filings into the joint when doing a acromioplasty procedure only when doing the ac joint resection of the procedure on (b)(6) 2023.This happened with same product under 2 different lot numbers lot 14557184 and 14918873.Customer does not like metal filings in the joint and was able to complete the procedure successfully by using the shaver to suck out the debris.The procedure took more time than normal to complete.The customer would like to be informed about why this occurs and if there were possible ways that arthrex could rectify it.
Additional Manufacturer Narrative
Additional information: the complaint allegation is confirmed.The device was not received for investigation.An image was provided with metal shavings that were being produced by the bone cutter.The most likely cause is attributed to misuse due to prying/leveraging the device against hard bone and/or tissue which creates surface damage across the inner and/or outer tube--thus indicating interference between two surfaces.According to dfu-0215-eo; f; #15: powerpick device tips can bind in bone and render the device inoperable if the device is stopped while inserted in bone and/or if the angle of the rotating tip is changed while drilling.Make sure handpiece is off while changing device tip position.

• Brand Name: BONE CUTTER,5.5MM X 13CM
• Common Device Name: SAW BLADE
• 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: 17918581
• Report Number: 1220246-2023-08148
• Device Sequence Number: 2971606
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: 00888867043930
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: BONE CUTTER,5.5MM X 13CM
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 14557184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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