MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL,FLEXIBLE,ENDOSCOPIC,CANN, 9MM; SAW, POWERED, AND ACCESSORIES

Catalog Number 7209738

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the drill bit broke off right at the distal tip during an acl case.Nothing broke in the patient and the case was not affected as they were able to finish with an alternate size drill bit.There were no reported patient injuries.No other complications were noted.

• Brand Name: DRILL,FLEXIBLE,ENDOSCOPIC,CANN, 9MM
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5970506
• MDR Text Key: 55681036
• Report Number: 1219602-2016-00859
• Device Sequence Number: 1
• Product Code: HAB
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 7209738
• Device Lot Number: 50536832
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Date Device Manufactured: 02/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1