MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL 4.5MM, DSPL., EP-1; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205306

Device Problem Bent (1059)

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

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported there were small shards of metal in the joint which appeared shortly after he had started using the full radius shaver blade.After we noticed this and the blade was removed from the joint by the surgeon, it appeared to be bent.A backup device was readily available.No delays or patient injuries were reported.

Manufacturer Narrative

Device investigation narrative - one used 4.5 mm full radius blade was returned for evaluation.Visual assessment of the blade showed it is dramatically bent.The blade was evaluated for rotation and was found not to rotate freely; friction was felt in the unloaded condition.The inner blade is heavily galled in multiple places along its length confirming the reported shedding.The condition of the blade indicates that an excessive lateral load was placed on the blade during use.Per the devices ifu (b)(4) ¿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¿.Further investigation is not warranted at this time.Credit has been issued as a customer courtesy.Device returned for evaluation, date received by manufacturer,: device evaluated by the manufacturer, evaluation codes updated.

• Brand Name: FULL RADIUS BL 4.5MM, DSPL., EP-1
• 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
• MDR Report Key: 6584038
• MDR Text Key: 75918660
• Report Number: 1219602-2017-00521
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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