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

Model Number	7205331
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International zip code: (b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10212187
• Report Number: 1219602-2020-00963
• Device Sequence Number: 19434151
• Product Code: HAB
• UDI-Device Identifier: 03596010251596
• UDI-Public: 03596010251596
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2024
• Device Model Number: 7205331
• Device Catalogue Number: 7205331
• Device Lot Number: 50803640
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR