MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA UNIVERSAL COMPACT H.R.ASSEMBLY; N/A

Catalog Number UCHRA

Device Problems Difficult To Position (1467); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The left intubation loop screw was unable to be loosened by the wrench.This made it impossible to position the intonation hoop post operatively.The device was in contact with the patient.There was no patient injury.There was no delay in surgery.

Manufacturer Narrative

Integra has completed their internal investigation on september 06, 2017.Results: evaluation of returned device; inspection found the unit was missing one latch.Also, one post/hoop screw was jammed and damaged.These parts need to be replaced.Repaint the scale.The unit needs to cleaned up.Dhr review; no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.Complaints history; no other prior complaints were received; no new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: no manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: UNIVERSAL COMPACT H.R.ASSEMBLY
• Type of Device: N/A
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6810382
• MDR Text Key: 83531100
• Report Number: 3004608878-2017-00251
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K160811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UCHRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2002
• 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