MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CURVED INCISOR PLUS ELITE BL,4.5MM,; SAW, POWERED, AND ACCESSORIES

Model Number	72200036
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dr.(b)(6) has been experiencing metal shavings, from the shaver, in the joint during his cases.He has seen metal shavings.Generally it happens in his acl and shoulder cases.
Additional Manufacturer Narrative
The device was received opened and used.The complaint stated: ¿dr.Has been experiencing metal shavings, from the shaver, in the joint during his cases.He has seen metal shavings.Generally it happens in his acl and shoulder cases¿.Visual inspection shows that this blade is in very good condition.It was functionally tested with a dyonics ep-1 mdu device with an ep-1 and an elite power max handset.It showed no out of the norm observation.There was no binding.The blade ran in forward, reverse and oscillating.It switched between modes with no issue.There was no error messages indicated on the unit power control panel.This complaint could not be replicated.Shedding has been found to be consistent with wear bands created from inadvertent excess side loading pressure being applied to the device.Per precautions: ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿ and it also notes: ¿irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ this device spins freely and shows no obstruction.The complaint cannot be confirmed.There have been no other reports of this failure mode for this production lot.

• Brand Name: CURVED INCISOR PLUS ELITE BL,4.5MM,
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7139291
• Report Number: 1219602-2017-01574
• Device Sequence Number: 1109587
• Product Code: HAB
• UDI-Device Identifier: 03596010555700
• UDI-Public: (01)03596010555700(17)220508(10)50663273
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2018

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 Expiration Date: 05/08/2022
• Device Model Number: 72200036
• Device Catalogue Number: 72200036
• Device Lot Number: 50663273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1