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

Catalog Number 7205326

Device Problems Device Slipped (1584); Metal Shedding Debris (1804)

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

Event Date 03/03/2014

Event Type  malfunction  

Manufacturer Narrative

One blade was returned for evaluation of the reported complaint mode "shedding/flaking.The device was inspected dimensionally and found to meet design requirements.Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition.The root cause has not been determined.The device history records were reviewed and no discrepancies were found.The company will continue to analyze additional complaints as they are reported.(b)(4).

Event Description

During a acromioplastic surgery, it was reported that the metal on the "inner stick" of the device turned and released metal shavings into the joint.In which this procedure was performed with the hard tissue.There was no visible damage or remnants of metal in the joint at the end of the surgery.It was reported that there was no damaged to the device or device packaging.

• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4938680
• MDR Text Key: 22890279
• Report Number: 1219602-2015-00437
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 7205326
• Device Lot Number: 50754875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2013
• 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