MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA STEM / SHAFT ASSY - 7.5MM; KATALYST BIPOLAR RADIAL HEAD SYSTEM

Catalog Number 221675

Device Problems Failure To Adhere Or Bond (1031); Loose or Intermittent Connection (1371); Malposition of Device (2616)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This event involved 2 devices, same procedure, same patient.This is the 2nd of 2 submissions.It was reported the surgeon could not snap the head onto the stem, the head popped off during surgery.It was reported, "i typically use the 1m position so there is less play for getting it in.I had to try 2 times to get it in, and i can only surmise that i may have deformed the poly edge getting it lined up before i clicked it together.However, that may be a bit of a stretch.It did not click very loudly or normally.Then later when we were ranging the elbow, we could see that it was loose.Used a second and all was fine.This one was a bit tight to put in." no patient injury was reported.

Manufacturer Narrative

This event involved 2 devices, same procedure, same patient.This is the 2nd of 2 submissions.Mfr report numbers: 3004608878-2015-00290; 3004608878-2015-00291.Integra has completed their internal investigation on 2feb2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: a review of the device history records indicated that the 7.5 mm stem assembly (lot # 10516) consisting of a quantity of (b)(4) devices, was manufactured by std medical and received at (b)(4) march 21, 2007, inspected and released into inventory on april 9, 2007 as lot number 105167511055.(b)(4).There were no variances or mmrs associated with the inspection.Seventeen of the 7.5 mm radial head stem assemblies were sent to ils san diego for re-packaging and gamma sterilization, returned to ils (b)(4) on december 6, 2012, inspected and released into inventory on december 14, 2012 as lot # 1051675110k12.There were no mrrs or variances associated with the inspected final packaged implants.A query in the electronic database found one additional customer complaint associated with the inability to properly assemble the radial head/poly assembly to the radial head stem assembly during surgery.The query was based on searching for (b)(4) and the three radial head/poly assembly implant part numbers, 221418, 221421 and 221424.The trend analysis did not look for complaints in which the radial head/poly assembly detached from the radial head stem assembly, post-operatively.The trend analysis failure rate was performed by determining the number of reported non-conformances for the particular implant.A failure rate percentage was determined by calculating the non-conformance rate as a function of the number of opportunities.A review of domestic and international ((b)(4) sales information determined that approximately (b)(4) radial head/poly assemblies were sold during the time frame of (b)(4) 2010 ¿ through 2015.The two reported complaints represent a failure rate of (b)(4).Conclusion: based on the review of available documentation and the dimensional analysis, the probable root cause was that the polyethylene insert was deformed during the initial attempt to attach the radial head poly assembly to the radial head stem assembly.The damage increased the opening of the polyethylene insert, decreasing it¿s capability to retain the head of the radial head stem assembly under physiological load.The polyethylene insert is part of the device associated with report 3004608878-2015-00290.

• Brand Name: STEM / SHAFT ASSY - 7.5MM
• Type of Device: KATALYST BIPOLAR RADIAL HEAD SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5231185
• MDR Text Key: 31686691
• Report Number: 3004608878-2015-00291
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K032806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221675
• Device Lot Number: 105167511055/1051675110K12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1