MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR,5.5MM ABRADER,180MML DISPOSABLE (3; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200082

Device Problems Flaked (1246); Metal Shedding Debris (1804)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the burrs were shedding and flaking into the patient.The metal shavings were removed and a backup device was available to complete the procedure without delay or patient impact.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation was limited to the information provided; the investigation could not draw any conclusions about the reported event without the return of the device in question.Further investigation is not warranted at this time.(b)(4).

• Brand Name: BURR,5.5MM ABRADER,180MML DISPOSABLE (3
• 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: james gonzales ; 7000 west william cannon drive; austin, TX
• MDR Report Key: 6685813
• MDR Text Key: 79129779
• Report Number: 1219602-2017-00691
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

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: 08/15/2019
• Device Catalogue Number: 72200082
• Device Lot Number: 50647251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 07/21/2017
• Supplement Dates FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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