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

Model Number 7205326

Device Problems Material Disintegration (1177); Knife (3156)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2018

Event Type  Malfunction  

Event Description

It was reported lost of metal blade fragments in the patient while scraping the bone. It is unknown if all the fragments were removed from the patient. No significant procedure delay was reported. Back up device was available.

Manufacturer Narrative

Due to no product return the complaint could not be ultimately confirmed. Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate. No further actions pursued at this time. If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.

• 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: 7681989
• MDR Text Key: 113785080
• Report Number: 1219602-2018-00894
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: DISTRIBUTOR,FOREIGN,HEALTH PR
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/12/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 7205326
• Device Catalogue Number: 7205326
• Device LOT Number: 50715057
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 02/15/2018
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 07/12/2018 Patient Sequence Number: 1