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

Model Number	72203952
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7336535
• Report Number: 1219602-2018-00329
• Device Sequence Number: 10907858
• Product Code: MAI
• UDI-Device Identifier: 00885554031713
• UDI-Public: (01)00885554031713(17)200512(10)50549467
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 58