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

Catalog Number 72200724

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

(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

See c-(b)(4) eleven shelf cartons of product (b)(4) (65 individual burrs; 10 cartons of 6 and one carton of 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.

• 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: 8100069
• MDR Text Key: 128565254
• Report Number: 1219602-2018-01618
• 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: 02/25/2019

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
• 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
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 11/23/2018
• Supplement Dates Manufacturer Received: 02/23/2019
• Supplement Dates FDA Received: 02/25/2019
• 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