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

Model Number 72203952

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/26/2018

Event Type  malfunction  

Event Description

It was reported that during arcr procedure, when surgeon use the dilator on humerus, the handle has came free from shaft and got inside the patient.This shaft was removed using a nipper.No patient injury was reported.

Manufacturer Narrative

One disposable 5.5 healicoil rg dilator returned.Complaint states: ¿it was reported that during arcr procedure, when surgeon use the dilator on humerus, the handle has came free from shaft and got inside the patient.This shaft was removed using a nipper.¿ visual inspection shows that the shaft has been replaced back into the handle.There are ¿nipper¿ marks where the shaft was removed from the patient and has been forced back into the handle.The patient was reported to have soft bone.Excessive force can result in instrument failure.No root cause related to the manufacturing of this device was established.

• 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: 7336535
• MDR Text Key: 102443507
• Report Number: 1219602-2018-00329
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554031713
• UDI-Public: (01)00885554031713(17)200512(10)50549467
• Combination Product (y/n): N
• PMA/PMN Number: K123393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

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
• Device Operator: No Information
• Device Expiration Date: 05/12/2020
• Device Model Number: 72203952
• Device Catalogue Number: 72203952
• Device Lot Number: 50549467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• 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
• Patient Age: 70 YR
• Patient Weight: 58