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

Model Number 7205326

Device Problem Material Disintegration (1177)

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

Event Date 07/13/2018

Event Type  malfunction  

Event Description

It was reported that when the surgeon was used the new probe, a lot of metal debris fell off.The surgeon continued to use the affected product to continue the surgery, at last used a blade to clean up all the debris.

Manufacturer Narrative

Device in question was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the return of the device.

• 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, TX 78735 ; 5123585706
• MDR Report Key: 7814697
• MDR Text Key: 118397090
• Report Number: 1219602-2018-01117
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: (01)03596010251541(17)220707(10)50673387
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: 7205326
• Device Catalogue Number: 7205326
• Device Lot Number: 50673387
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1