MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL TAPERED 3.8MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201915
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip detached from the handle at the first hammer.They fixed the instrument with tape and finished the surgery.The tip broke inside the patient and all the pieces were removed from the patient.
Additional Manufacturer Narrative
One 72201915 3.8mm tapered awl was returned.This is an eight year old reusable instrument.The complaint stated: ¿¿the tip detached from the handle at the first hammer.¿ there are typical surface scratches on the shaft from reuse.The delrin handle has lost its press fit stability and eventually stripped.The device also has heavy etching, dings and scratches on surfaces.The instrument handle is quite etched.Materials and the press fit have been deteriorated.This is consistent with use of incompatible cleansing agents.This includes washing/sterilizing methods.In addition, these handles are subject to friction upon loading and unloading during sterilization.No root cause related to the manufacturing process was established.

• Brand Name: AWL TAPERED 3.8MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8455941
• Report Number: 1219602-2019-00355
• Device Sequence Number: 354536
• Product Code: NBH
• UDI-Device Identifier: 03596010610607
• UDI-Public: 03596010610607
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2019

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 Catalogue Number: 72201915
• Device Lot Number: 50374928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1