MAUDE Adverse Event Report: SKELETAL DYNAMICS IMPLATE WRIST ARTHRODESIS NAIL; NONE

Device Problems Difficult to Remove (1528); Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 11/21/2013

Event Type  No Answer Provided  

Event Description

A skeletal dynamics implate installed by dr (b)(6) on (b)(6) 2012.The skeletal dynamics implate was approved by the fda in the summer of 2010.It was determined on (b)(6) 2013, that the implate had failed and needed to be explanted.A skeletal dynamics representative was notified by dr (b)(6) via telephone on (b)(4) 2013 at approximately 10:45 am est about the failure and was posed the question of if/how could the implate be explanted.Dr (b)(6) was told that it had been explanted before.The skeletal dynamics implate was explanted on (b)(6) 2014.Excerpts from the operative report indicate "the 2 locking screws in the implate to the connector were loose.The intramedullary nail in the third metacarpal was also loose." the procedure was expected to take two to two and half hours.It took over five hours.The implate is not designed for explantation after union or partial nonunion.Bone had to be removed to successfully explant the device.Following the surgical procedure to remove the skeletal dynamics implant, patient has received a partial impairment rating of 30 percent right extremity and 18 percent whole body.There is notation of reduced mobility/use of right thumb.Grip strength 10 months post surgery in right dominant hand is 48 lbs.Mathiowetz scale indicates 119.7 lbs for gender and age.Grip strength endurance deteriorates rapidly with use.It was determined by dr (b)(6) (independent medical exam on (b)(6) 2014) that the result of the procedure to remove the implate was ankylosis of the right hand/wrist.That was concurred by dr (b)(6) (letter dated (b)(6) 2014) that stated, "most recently, (b)(6) 2013, he underwent a revision arthrodesis.The revision arthrodesis resulted in complete ankylosis of the wrist." (b)(4) have concurred that skeletal dynamics implant failed and approved the condition (b)(6).Skeletal dynamics, (b)(6) failed to retain the failed skeletal dynamics implate for further inspection once explanted.(b)(6) denied patient's request on (b)(6) 2013.

• Brand Name: IMPLATE WRIST ARTHRODESIS NAIL
• Type of Device: NONE
• Manufacturer (Section D): SKELETAL DYNAMICS
• MDR Report Key: 4135459
• MDR Text Key: 15123408
• Report Number: MW5038410
• Device Sequence Number: 1
• Product Code: JDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/25/2014

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?: Yes
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 107