MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. BERTRAND FENESTRATED INSERT CURVED 450MM; PFM16

Catalog Number CEV9625C

Device Problems Material Discolored (1170); Stretched (1601); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

The instruments went under 1 or 2 cycle of sterilization and they started losing its shape, rotating device got stuck, insulating cover over the shaft started expanding from the actual length, insulating cover started having rough humps over the entire shaft, metal part started changing color.No patient contact or injury reported.

Manufacturer Narrative

Integra has completed their internal investigation on january 11, 2018.Results: dhr review; unable to review the applicable dhr as the lot no.Was unavailable.Complaints history; no adverse trend - first occurrence of this risk for this device.Conclusion: a complaint investigation (failure analysis) and determination of root cause is not possible as the complaint could not be verified due to lack of sample.

Manufacturer Narrative

The following mdrs medwatch numbers: 2523190-2017-00162, 2523190-2017-00163, 2523190-2018-00007, 2523190-2018-00008, 2523190-2017-00161 were submitted in error.Documentation review of our risk management files confirmed the reported failure mode as non-critical and within the acceptability range.Integra has recently undergone a restructuring of our complaint department.Subsequent restructuring has led to a more vigilant oversight in the complaint risk review process.While performing the complaint closure process it was noted the risk was incorrectly assigned.As a result, we have retrained all parties involved.

Manufacturer Narrative

Integra has completed their internal investigation on january 29, 2018.There are some circular white light stains on the surface of the instrument.These stains are not the beginning of an oxidization of the instruments but a thin deposit coming from chemicals.There is no issue for assembling with a handle and functioning.No anomalies that could be associated with the complaint were observed the most probable cause of the white stains is cleaning water or rinsing water too hard.The coloration of the instruments comes from the use of improper reprocessing water.It must contain chemicals such as iron, copper, manganese or silicates.

• Brand Name: BERTRAND FENESTRATED INSERT CURVED 450MM
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7154921
• MDR Text Key: 96238153
• Report Number: 2523190-2017-00162
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K993655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV9625C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 01/11/2018; 01/29/2018; 02/07/2018
• Supplement Dates FDA Received: 01/15/2018; 01/29/2018; 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2016
• 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