MAUDE Adverse Event Report: ARTHREX, INC. DOUBLECUT, 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number DOUBLECUT, 4.0MM X 13CM

Device Problem Corroded (1131)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2019

Event Type  Injury  

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.

Event Description

It was reported that during a shoulder arthroscopy procedure, the surgeon was doing a decompression and the oval burr, ar-8400obe was producing metal flakes in the joint.No further information.Additional information requested.Additional information provided 6/12/2019: the shavings looked like glitter in the joint and were probably not retrieved.The case was completed with a new shaver.Additional information provided 6/13/2019: the account has two blades from the case.They also used an ar-8400dc, lot: 10274224.In addition to the ar-8400obe and they aren¿t 100% sure which one produced the metal flakes, so they saved both.

Manufacturer Narrative

The complaint could not be confirmed.Visual evaluation revealed no surface damage to the inner diameter of the ar-8400dc outer hub, or any damage on the corresponding location at the distal end of the inner tuber that would indicate a site of metal debris production.Material analysis showed the returned ar-8400dc met all as-received specifications.No problem found.

• Brand Name: DOUBLECUT, 4.0MM X 13CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: vik bajnath ; 8009337001
• MDR Report Key: 8735392
• MDR Text Key: 149238396
• Report Number: 1220246-2019-01176
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867043565
• UDI-Public: 00888867043565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: DOUBLECUT, 4.0MM X 13CM
• Device Catalogue Number: AR-8400DC
• Device Lot Number: 10274224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other