MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPADE DRILL BIT FOR 2.9 ANCHOR; SAW, POWERED, AND ACCESSORIES

Catalog Number	72201395
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was peeled off when screwing the bone.No delay and a back up was available to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
One 72201395 spade drill bit for 2.9 anchor used for treatment, was not returned for evaluation.This is a reusable instrument.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were limited without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Prep per the instruction for use recommendation is critical for ease of insertion and successful anchoring.Per instruction for use: ¿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.¿ product met specifications upon release to distribution.
Additional Manufacturer Narrative
One 72201395 spade drill tip for 2.9 anchor used for treatment, was returned for evaluation.This is a six year old reusable instrument.Periodic maintenance checks are recommended for reusable instruments.Inspection prior to use is required.Wear from repeat use and cleanings was apparent.The product description, code and lot were nearly worn off.Visual inspection confirmed that the diameter of the distal shaft had rotational surface skiving.There were dings and chips noted on the spade.The very distal tip was rolled over as with blunt force.Contact with other instruments or devices had occurred.These symptoms indicate that grit from the skiving produced the shedding observation.Per instructions for use: ¿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 failure¿.No root cause related to the manufacture of the device was confirmed.

• Brand Name: SPADE DRILL BIT FOR 2.9 ANCHOR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8927980
• Report Number: 1219602-2019-01007
• Device Sequence Number: 2206382
• Product Code: HAB
• UDI-Device Identifier: 03596010595546
• UDI-Public: 03596010595546
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2019

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: 72201395
• Device Lot Number: PCE17809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 09/18/2019; 11/13/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/19/2019; 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR