MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR BLADE,BOXED4.5 EP-1; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, a delay of more than 30 minutes was caused due to the surgeons found a metal debris when they were using a planer to cut soft tissue.After washing with saline, some metal debris remains in the patient's joint cavity.Unknown if backup was available and how the issue was resolved, but no patient injury was reported.
Additional Manufacturer Narrative
One 4.5mm synovator blade was returned for evaluation.Functional inspection was performed and the inner blade did not rotate freely within the outer blade, friction was felt in the unloaded condition.Visual assessment of the inner blade showed multiple contact points along its length with extensive abrasion.The outer blade is bent.All indications point to the excessive lateral load being applied to the blade during use.Per the devices ¿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¿.The material of the synovator blade is 304l stainless steel which is not an implantable alloy; therefore, long-term implantation data is not available.The patient impact is related to the retained metal shavings and its associated effects as well as the surgical delay during surgery.

• Brand Name: SYNOVATOR BLADE,BOXED4.5 EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8108168
• Report Number: 1219602-2018-01631
• Device Sequence Number: 16685672
• Product Code: HAB
• UDI-Device Identifier: 03596010251381
• UDI-Public: 03596010251381
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 7205310
• Device Lot Number: 50589145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR