MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIONIZER,4.0 EP-1,DSPL BL; SAW, POWERED, AND ACCESSORIES

Model Number 7205326

Device Problem Material Separation (1562)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

International zip code: (b)(6).

Event Description

It was reported that during an unknown procedure, the acromionizer broke off inside the patient and the broken pieces were removed.The procedure was completed with a back up device with no delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported 4.0 acromionizer burr, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the burr broke during use, broken pieces were removed from the patient.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: ACROMIONIZER,4.0 EP-1,DSPL BL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9527680
• MDR Text Key: 173802568
• Report Number: 1219602-2019-01652
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: 03596010251541
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205326
• Device Catalogue Number: 7205326
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1