MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE ACROMIONIZER BURR(6); SAW, POWERED, AND ACCESSORIES

Catalog Number 72200724

Device Problems Material Fragmentation (1261); Failure to Cut (2587)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6) zip code: (b)(6).

Event Description

It was reported that it takes a lot of effort for the bone cutter to take some of the bone.The bone cutter blade produced small chips of metal in the joint.They were removed by flushing out.A backup device was available to complete the procedure with no significant delay and no patient injuries.

Manufacturer Narrative

Eleven shelf cartons of product 72200724 (65 individual burrs; 10 cartons of 6 and one carton of 5) were returned from lot 50741489.They are all new and unsealed.The product used in the procedure was not returned for evaluation.Definitive conclusions, accurate investigation and evaluation were not definitive without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device ability, surgical ability, procedure location, tissue condition and use per product recommendations.Influences that could compromise product performance or integrity that are unrelated to manufacture include: blade hand piece not fully loaded and or locked into mdu hand set.Incompatible force, torque or leverage applied.Unexpected bone density/condition.Change of approach during use.Insufficient irrigation or engaging the device without suction.Seizing of blades due to inadequate bio matter excision.Use not compliant with instructions for use, tech guides or specific procedure.Per instructions for use: ¿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.Make sure the hand piece is off while changing blade tip position.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry)¿.Final product met predetermined specs upon release to distribution.No patient harm or injury is being reported as a result of this device related incident, and all of the metal debris was flushed out.There is no indication of adverse patient consequence as a result.

Event Description

It was reported that, during an unknown procedure, it took a lot of effort for the bone cutter to take some of the bone.The bone cutter blade produced small chips of metal in the joint.They were removed by flushing out.A back-up device was available to complete the procedure with no significant delay and no patient injuries.

• Brand Name: DYONICS 4.0MM ELITE ACROMIONIZER BURR(6)
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8100087
• MDR Text Key: 128266622
• Report Number: 1219602-2018-01622
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010578020
• UDI-Public: 03596010578020
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2023
• Device Catalogue Number: 72200724
• Device Lot Number: 50741489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1