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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. ACROMIONIZER,4.0 EP-1,DSPL BL SAW, POWERED, AND ACCESSORIES Back to Search Results
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.

 
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Brand NameACROMIONIZER,4.0 EP-1,DSPL BL
Type of DeviceSAW, 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 Key7681989
MDR Text Key113785080
Report Number1219602-2018-00894
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberEXEMPT
Number of Events Reported1
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 Received07/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7205326
Device Catalogue Number7205326
Device LOT Number50715057
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 Received08/14/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/15/2018
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
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