MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. UNIVERSAL COMPACT H.R.ASSEMBLY; N/A

Catalog Number UCHRA

Device Problems Fitting Problem (2183); Out-Of-Box Failure (2311)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The uchr adapter plate does not fit properly onto the head ring.It required spreading of the adapter plate which displaced the location of the locating sockets and deemed the unit unworkable.There was no patient contact or patient injury.There was no patient prepped for surgery.There was no surgery delay.Out of box failure was reported.

Manufacturer Narrative

Integra has completed their internal investigation on 12jan2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: in comparing the parts produced prior to the transfer, the parts manufactured at burlington measured at 60 degrees, where the adapter rings produced at integra ohio measured at 45 degrees.Note this feature is not defined on the part drawing.Device history record reviewed for this product id lot # 130329136, s/n 902, 903, 909 and 910 manufactured on may 05, 2015 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.A review of complaints history revealed a total of four customer complaints, including this complaint.Conclusion: the end users experience was verified.Capa has been initiated to address this issue.

• Brand Name: UNIVERSAL COMPACT H.R.ASSEMBLY
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; 22 terry avenue; burlington MA 01803
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5210615
• MDR Text Key: 31038230
• Report Number: 1222895-2015-00040
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UCHRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1