MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG DILATOR 5.5MM DISPOSABLE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72203952

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/09/2018

Event Type  malfunction  

Event Description

It was reported that the black plastic handle portion disengaged from the actual metal rod.When trying to turn the tap, only the handle would turn and not the metal portion.No patient injury was reported.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

Event Description

It was reported that the black plastic handle portion broke from the actual metal rod.When trying to turn the tap, only the handle would turn and not the metal portion.

• Brand Name: HEALICOIL RG DILATOR 5.5MM DISPOSABLE
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 7509683
• MDR Text Key: 108264301
• Report Number: 1219602-2018-00567
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203952
• Device Lot Number: 50603963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1