MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,5.5MM DSPL. EP-1; SAW, POWERED, AND ACCESSORIES

Model Number 7205307

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2018

Event Type  malfunction  

Event Description

It was reported that during the surgery metal blade fragments were lost in the patient while the bone was being scrapped.No patient injury was reported.Back-up device was available.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: FULL RADIUS BLADE,5.5MM 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 ; arthrocare corporation; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7616638
• MDR Text Key: 111940206
• Report Number: 1219602-2018-00766
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251350
• UDI-Public: (01)03596010251350(17)221115(10)50697402
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

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: 11/15/2017
• Device Model Number: 7205307
• Device Catalogue Number: 7205307
• Device Lot Number: 50697402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 08/01/2018
• Date Device Manufactured: 11/15/2017
• 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
• Patient Age: 74 YR