MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNIFE RASP; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201661
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during shoulder surgery the device broke into three pieces.It is unknown whether there was a backup device available.No delay or patient injury was reported.
Additional Manufacturer Narrative
One elite premium rasp knife used for treatment but 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.Instructions for use confirms instructions, precautionary statements and recommendations for proper use of product.Influences that could compromise product performance or integrity include: 1) current recommended maintenance.2) entanglement with other instruments or devices during use or cleaning.1.Compliant use of instrument.2.Careful cleaning and sterilization of product.3.Entanglement with other instruments or devices during use or cleaning.4.Pressure or excess torque applied.Per instructions for use: ¿these instruments are designed for repeated use with proper care and handling.¿ instrument tips may inadvertently be twisted or caught on other instruments or the basket during cleaning.This can lead to compromised strength.¿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 72201661 elite premium knife rasp instrument used for treatment, was returned for evaluation.This is a six year old reusable product.The complaint stated: ¿the device broke into three pieces.¿ this was confirmed.The instrument was fractured at both ends of the shaft.The shaft itself was visibly bowed.Per ifu: ¿these instruments are designed for repeated use with proper care and handling.¿ instrument tips may inadvertently be twisted or caught on other instruments or the basket during cleaning.This can lead to compromised strength.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.¿ there are no other complaints for this lot.This allegation is considered an isolated incident.Product met specifications upon release to distribution.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: KNIFE RASP
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8762785
• Report Number: 1219602-2019-00780
• Device Sequence Number: 2296348
• Product Code: NBH
• UDI-Device Identifier: 03596010606297
• UDI-Public: 03596010606297
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2019

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: 72201661
• Device Lot Number: 50457546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 09/10/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 08/13/2019; 09/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR