MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 5.5MM FULL RADIUS PLATINUM SERIES; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203522

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the 5.5mm full radius platinum series blade was shedding metal fragments in the patient's joint.A 2nd blade, same lot#, was used to finish the case.Reportedly, most of the fragments were recovered but some remained in the patient because they were so small.No fluoro or xray was used to locate additional pieces.There was a reported delay of less than 30 minutes as the result of the reported incident.

Manufacturer Narrative

Device investigation narrative - one 5.5mm full radius blade was returned for evaluation.Visual assessment identified multiple contact points on the inner blade coupled with corresponding debridement of the outer blade confirming the complaint of shedding.Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition.The device was inspected dimensionally and found to meet design requirements.It appears that an excessive lateral load was placed on the blade during use.Per the devices ifu ¿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¿.No further investigation is warranted at this time.(b)(4).

• Brand Name: 5.5MM FULL RADIUS PLATINUM SERIES
• 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 78735 ; 5123585706
• MDR Report Key: 5507775
• MDR Text Key: 40582822
• Report Number: 1219602-2016-00143
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: 72203522
• Device Lot Number: 50707487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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
• Patient Outcome(s): Required Intervention