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	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Describe event or problem updated.
Event or Problem Description
It was reported that during a surgery, the tip of instrument broke off during use.There was not delay and was not backup available, that portion of the procedure was therefore aborted.According to the customer knowledge the piece was not remove.No patient injury was reported.
Event or Problem Description
It was reported that during a surgery, the tip of instrument broke off during use.Unknown delay and unknown if backup was available and how the issue was resolved.Unknown if the pieces were remove but no patient injury was reported.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.A photograph was supplied showing the tip of the awl has broken off.The break area shows evidence of plastic deformation.The device is over ten years old.The condition of the device indicates it was subjected to excessive forces during use.Per the devices instructions for use under precautions ¿as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in the instrument¿s failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges¿.No root cause related to the manufacturing process can be established.The 17-4ph is not an implantable alloy; therefore, long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and probable restrictions cannot be determined, as it was reported the patient¿s current status was unknown and the surgeon had no plans to remove the broken fragment/foreign body.

• 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: 8105515
• Report Number: 1219602-2018-01629
• Device Sequence Number: 2165285
• Product Code: NBH
• UDI-Device Identifier: 03596010610607
• UDI-Public: 03596010610607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2019

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: 50242532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 02/19/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 11/28/2018; 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 95