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

Model Number 7205327

Device Problem Material Disintegration (1177)

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

Event Date 07/25/2018

Event Type  malfunction  

Event Description

It was reported that the device put metal shavings into the joint while in use.All the pieces were removed.A backup device was available to complete the procedure with no significant delay and no patient injuries.

Manufacturer Narrative

One used 5.5 mm acromionizer burr was returned for evaluation.Visual assessment of the burr showed a contact point on a section of the inner sheath which coincides with the bronze bushing.Dimensional assessment found the device met print specifications.The burr was shed tested and the reported shedding was confirmed.A re-design the inner burr has been initiated, as part of the re-design the bronze bushing will be replaced by a secondary shrink tubing.This improvement will eliminate this mode of shedding.

• Brand Name: ACROMIONIZER,5.5,EP-1,DSPL BL(6)
• 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, TX 78735 ; 5123585706
• MDR Report Key: 7797009
• MDR Text Key: 117708198
• Report Number: 1219602-2018-01095
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251558
• UDI-Public: (01)03596010251558(17)220713(10)50674360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: 7205327
• Device Catalogue Number: 7205327
• Device Lot Number: 50674360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2017
• 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