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

Model Number 7205326

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/21/2017

Event Type  malfunction  

Event Description

It was reported that during procedure the acromionizer device presented its blade ribbing against the metal sheath with no shedding or flaking.A backup device was available to complete the procedure with no patient injuries.Per customer¿s response the device ran continously.

Manufacturer Narrative

One 7205326 4.0mm ep-1 disposable acromionizer blade returned.The complaint allegation stated: ¿it was reported that during procedure the acromionizer device presented its blade ribbing against the metal sheath with no shedding or flaking.A backup device was available to complete the procedure with no patient injuries.Per customer¿s response the device ran continuously.¿ the blade was tested with a dyonics handset and showed no irregularities.The device produced a typical whirring sound of the inner blade rotations.The complaint could not be duplicated.It could have been temporary difficulty with excising of tissue and bone fragments.Returns of this nature have been found to be consistent with the device being ¿tested¿ with insufficient or without irrigation and suction.No root cause related to the manufacturing of this device was established.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin 78735
• MDR Report Key: 7526697
• MDR Text Key: 108867764
• Report Number: 1219602-2018-00611
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: (01)03596010251541(17)220203(10)50645208
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Model Number: 7205326
• Device Catalogue Number: 7205326
• Device Lot Number: 50645208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2017
• 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