MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STONECUTTER ACR EP-1 5.5 DSPL; SAW, POWERED, AND ACCESSORIES

Model Number 7205331

Device Problem Flaked (1246)

Patient Problem Injury (2348)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

International zip code: (b)(6).

Event Description

It was reported that during an arthroscopy surgery, it was found that the blade had metal abrasion.All the material was vacuumed from the patient's anatomy.No significant delay was reported and the surgery was finished using a smith and nephew back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 7205331 disposable stonecutter acromionizer blade used for treatment, was returned for evaluation.Ifu confirms precautionary statements and recommendations for proper use of product.Visual evaluation confirmed that the burr was used and had small dings on blade edges.The condition is aligned with the blade having contact with another instrument, device or hard bone damage.Being tested or run without or with inadequate suction and irrigation is also a potential factor as poor excision of materials can cause blade damage.Per ifu: ¿irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).¿ binding and seizing may occur due to bone, tissue or metal shavings, fragments not excising efficiently.Per ifu: ¿irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ complaint history review indicated no similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: STONECUTTER ACR EP-1 5.5 DSPL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10212187
• MDR Text Key: 196952719
• Report Number: 1219602-2020-00963
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251596
• UDI-Public: 03596010251596
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205331
• Device Catalogue Number: 7205331
• Device Lot Number: 50803640
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR