MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPADE DRILL BIT FOR 2.9 ANCHOR SAW, POWERED, AND ACCESSORIES

Catalog Number 72201395

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2018

Event Type  Malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that item has snapped inside the patient's bone during surgery but due to the depth of the snapped part the surgeon has left the snapped part inside the patient. A backup device was available to complete the procedure with no delay or patient injuries.

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. Information added.

• Brand Name: SPADE DRILL BIT FOR 2.9 ANCHOR
• 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
• MDR Report Key: 7608364
• MDR Text Key: 111846593
• Report Number: 1219602-2018-00747
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: DISTRIBUTOR,FOREIGN,OTHER,USE

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/16/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 72201395
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse