MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIONIZER,5.5,EP-1,DSPL BL(6); SAW, POWERED, AND ACCESSORIES

Model Number	7205327
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at the end of a shoulder arthroscopy, it was noticed that the acromionizer appeared to leave a burn on the patient at the entry site of the burr.The procedure had already been completed without delay using the same device.No patient injury or 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 7205327 disposable 5.5mm ep-1 acromionizer blade used for treatment, was returned for evaluation.Overheating or melted blade conditions are consistent with being tested or run without or with inadequate suction and irrigation.Sufficient cooling and suction adjustments are operator responsibility.Per instructions for use 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).Nor is it intended to be engaged without suction.Blue debris from the product was noted where the sluff chamber and adapter body began to melt as well as down between the blade components toward the distal tip.All blades require sufficient cooling as a necessary consideration.The sales representative relayed that post procedure, the surgeon agreed what most likely occurred was ¿he was not allowing the suction to pull enough fluid through the burr while he was working.¿ the prior sentence confirms user responsibility.(in addition, the ¿probable root cause¿ was documented as ¿user error¿.) product met specifications upon release to distribution.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition or product/procedure failure that supported the allegation.No root cause related to the manufacturing of the device was established.Risk management reviewed the failure mode analysis for inclusion of this failure.Based on the information provided the root cause of the reported patient burn was likely due to a user vs procedural event.The patient impact beyond the reported events cannot be determined.No further investigation required at this time.

• Brand Name: ACROMIONIZER,5.5,EP-1,DSPL BL(6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9442958
• Report Number: 1219602-2019-01533
• Device Sequence Number: 10882679
• Product Code: HAB
• UDI-Device Identifier: 03596010251558
• UDI-Public: 03596010251558
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 7205327
• Device Catalogue Number: 7205327
• Device Lot Number: 50819816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 03/08/2020
• 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: Other
• Patient Age: 45 YR