MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG DILATOR 4.75MM DISPOSABLE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72203951
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft rotates freely within the handle after popping sound of handle.The dilator was in a caput humeri, and it was removed with other instrument.No patient injuries were reported.
Additional Manufacturer Narrative
Visual assessment showed the shaft has migrated 1.5 inches out of the handle confirming the reported complaint.Dimensional inspection of the shaft confirmed it met print requirements.A review of the ncmr database was performed which confirmed no abnormalities were reported with this lot during manufacture.A complaint history review identified no additional complaints for this manufactured lot.Device returned for evaluation device evaluated by the manufacturer evaluation codes updated.

• Brand Name: HEALICOIL RG DILATOR 4.75MM DISPOSABLE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6857898
• Report Number: 1219602-2017-01103
• Device Sequence Number: 10937485
• Product Code: MAI
• UDI-Device Identifier: 00885554031706
• UDI-Public: (01)00885554031706(17)200506(10)50548629
• Combination Product (Y/N): N
• PMA/510(K) Number: K123393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2015
• Device Model Number: 72203951
• Device Catalogue Number: 72203951
• Device Lot Number: 50548629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 09/21/2017; 10/03/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 09/27/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR