MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA INSERTER; COMPLETE IBD

Catalog Number 27-40-0000

Device Problems Bent (1059); Use of Device Problem (1670); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

It was reported the instrument bent during a case.The surgeon used the device to try to reposition an implant.The device was not designed for this use.The device did not, in anyway, fail or cause injury to the patient.The shaft on the instrument got a little bent.It was easily straightened out and works fine.It was reported the surgery was completed, there was a spare available and the spare functioned properly.It was initially reported the instrument was being used according to instructions for use.It was later reported this was not accurate.Although the event occurred during a procedure, there was no harm caused to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Integra has completed their internal investigation on 4aug2015.The additional investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: during the review of the stand alone ibd inserter 27-40-0000 dhr for lot w17922, it was concluded that the product was inspected and accepted for use by the (b)(4) quality control department on 8/2/2013 with temporary deviation tda 0022-13 in place for product labeling that changed ce marking on the label prior to drawing changes that affect the change.The inspection report indicates the devices met all specified parameters of the (b)(4) inspection report with no associated nonconformance specific to the product issue.Three of the devices were processed an addition time consisting of a labeling rework completed on 8/12/82013 with inspection limited to labeling and repackaging.In the past 12 months from the awareness date, ((b)(6) 2015), there have been 4 additional complaints concerning inserter damage and based on 12 months of sales data 2,447 complete cervical kits have been distributed which results in a.2% occurrence.Conclusion: based on the available information, it appears the root cause of the observed failure was likely due to surgeon technique during implant.If the inserter is not properly handled, it can be damaged during use.

• Brand Name: INSERTER
• Type of Device: COMPLETE IBD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 8006542873
• MDR Report Key: 4759533
• MDR Text Key: 15224001
• Report Number: 3004608878-2015-00137
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 27-40-0000
• Device Lot Number: W17922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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