MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MCP SZ. 20 DISTAL WW

Catalog Number MCP-100-20D-WW

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on 16dec2015.The investigation included: methods: -review of device history records.-review of complaint history.Results: the review of manufacturing records showed no evidence of nonconformance that could have caused or contributed to the reported defect.Complaints related to difficulty implanting devices as well as implant fit, difficulty removing implants, and intra-op/post-op implant fractures were included for trending, resulting in 35 complaints reported during the last 5 years.During the last 5 years, there have been (b)(4) units sold.The resulting overall rate of complaints is (b)(4).A negative yearly trend has not been identified, but since the reported complaints included adverse events with serious severity ratings, it is considered an adverse trend.Conclusion: the implants or trials were not returned; therefore, a root cause could not be identified at this time.

Event Description

It was reported there was a discrepancy with sizing of trial vs implant devices.When the set was returned to the distributor, the hospital indicated that the trial implants are smaller than the real implant (same size indicated but different size in reality).The hospital thought that trial implants are perhaps used.When the set was received, the distributor checked the trial implants.They are correct not damaged and not broken.The distributor thought that perhaps the "real" implanted implants have not the correct size/dimensions.It was later reported that the surgery could be finished.The surgeon had difficulties regarding the difference between size of final implants and trial implants.The patient was not directly impacted by this matter but the surgeon had to adapt to the issue.

• Brand Name: MCP SZ. 20 DISTAL WW
• Type of Device: MCP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5313452
• MDR Text Key: 33969267
• Report Number: 1651501-2015-00045
• Device Sequence Number: 1
• Product Code: NEG
• Combination Product (y/n): N
• PMA/PMN Number: P000057
• 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
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCP-100-20D-WW
• Device Lot Number: 141914T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2014
• 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