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

Model Number	72201915
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that while tapping the gold awl into the bone, the plastic black cap on the top of the awl broke off.All of the pieces were removed and spade drill was used to finish bone prep.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Additional Manufacturer Narrative
One 3.8mm tapered awl was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.The shaft of the device has broken where it transitions in diameter.The break area shows no material voids.The device was tested for material condition and found to meet print specification.The device is over four years old and shows normal wear.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: application of excessive force.As with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.

• 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: 7931885
• Report Number: 1219602-2018-01357
• Device Sequence Number: 19046732
• Product Code: NBH
• UDI-Device Identifier: 03596010610607
• UDI-Public: (01)03596010610607(10)50521878
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2019

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 Model Number: 72201915
• Device Catalogue Number: 72201915
• Device Lot Number: 50521878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/07/2018; 05/20/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/08/2018; 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1