MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA; NONE

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This event involves two devices and two mdr submissions.This is the first of two reports.It was reported the radial head device would not snap into the stem of the hex driver."the head would not snap into the stem.I applied so much force trying to do this that the screw driver broke in the head." there were two of each size available so the user was able to use the other head.A screw driver from a different manufacturer was used.It fit the second head.It was later reported that the surgeon indicated when he went to use the forceps clamp in the set to snap the radial head and stem together, the tip of the driver broke off in the radial head implant.It was reported there was no pt injury.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra completed its internal investigation june 11, 2015.Results: a review of the device history records could not be performed since the 21 mm radial head/ poly assembly implant involved in the complaint was not returned for evaluation and the lot number was not provided either in the initial complaint or in follow-up correspondence.A query in the electronic database did not find any other customer complaints associated with the inability to snap the radial head/ poly assembly implant to the stem assembly implant.A review of sales figures determined that integra has sold (b)(4) katalyst radial head implants during the time period of 2009 - april 19, 2015.The single reported non-conformance equates to a frequency of (b)(4) for the same time frame.Conclusion: the root cause for this complaint could not be determined.Since the device associated with this complaint was not returned for evaluation, integra is unable to determine if the inability to snap together the 21 mm radial head/poly assembly and the stem assembly was due to a manufacturing defect to the radial head 21 mm radial head/poly assembly.

• Type of Device: NONE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4768678
• MDR Text Key: 5777753
• Report Number: 3004608878-2015-00142
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1