MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STONECUTTER ACR,EP-1,5.5 DSPL; SAW, POWERED, AND ACCESSORIES

Model Number 7205331

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the blade was shedding during the procedure.A backup device was available to complete the procedure without patient impact.

Manufacturer Narrative

Three 5.5 ep-1 stonecutter burrs were returned for evaluation.Visual assessment of the burrs showed no evidence of debridement/shedding on the inner burr or outer sheath.Functional inspection was performed and the inner burrs rotated freely within the outer sheaths, no friction was felt in the unloaded condition.The reported shedding could not be confirmed.No root cause related to the manufacture of the device can be established.No further investigation is warranted at this time.A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: STONECUTTER ACR,EP-1,5.5 DSPL
• 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
• MDR Report Key: 7051511
• MDR Text Key: 92973022
• Report Number: 1219602-2017-01456
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251596
• UDI-Public: (01)03596010251596(17)220315(10)50652938
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: 7205331
• Device Catalogue Number: 7205331
• Device Lot Number: 50652938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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