MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWERMINI, WITH HAND CONTROLS; SAW, POWERED, AND ACCESSORIES

Catalog Number 72201500

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/12/2015

Event Type  Injury  

Event Description

During a wrist arthroscopy using a dyonics powermini, with hand controls, it was reported that the handpiece would not fix in the shaver box.A second handpiece, with a different serial number; yielded the same results.The patient was under for about 40 minutes and had to be awakened.The procedure was aborted since facility did not have any other handpieces.There were no reports of patient complications.

Manufacturer Narrative

Investigation of the returned device evaluation of the complaint of failure to fit product's cable connector into mdu receptacle on test control unit was confirmed.Product¿s cable connector has a bent guide key inside that prevents mdu from plugging into dii control unit receptacles.Rough handling when plugging and unplugging cable connector has bent guide key over time making it impossible to insert connector into receptacle.Mdu is almost 5 years old.(b)(4).

• Brand Name: DYONICS POWERMINI, WITH HAND CONTROLS
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4950819
• MDR Text Key: 22056676
• Report Number: 1643264-2015-00088
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72201500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2015
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other