MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF 5; DURASEAL SPINE

Catalog Number 206320

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/10/2016

Event Type  malfunction  

Event Description

On (b)(6)2016, the 206320 duraseal exact spine sealant system - 3 ml vial was found to have two vials with the powder content empty.The problem with the first vial was discovered at the time of the surgery.When checking the other products in stock it was identified that there was a second vial that did not contain the powder content.The units were from the same lot.The patient was prepped for surgery and the first empty vial incident caused a 1 hour delay in the surgery.There was no patient injury or medical revision required.

Manufacturer Narrative

Integra has completed their internal investigation on 01/31/2017.The investigation included: methods: review of device history records, review of complaints history.Results: the product sample or additional supporting materials from the account was not available for this incident.A review of the device history records has been performed for all potential lot information provided by the account.This review confirmed that the products were released meeting all medtronic quality release specifications at the time of manufacture.Without the physical product, a definitive root cause could not be identified.Historical complaint data displayed no trend for the failure/complaint mode.Pmv will continue to monitor this condition for future potential action conclusion: the clinically applied product was not returned to us for evaluation; therefore, we are unable to identify the specific cause for the problem reported.However, refer to the investigation findings for potential causes.If additional information is obtained, or the sample is returned, we will re-open this investigation.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Investigation completed 05/17/17.Method: -device history review, -trend analysis, -failure analysis.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.A review of the current historical complaint data reveals no trend for a device related failure for this condition.Visual and functional testing of the returned sample confirmed the product did not meet quality release specifications that were tested regarding the reported condition due to the melted peg confirmation of the reported condition.Conclusion: the file will be closed as improper storage **replication of the observed condition can be caused by storage above the indicated temperature range.

• Brand Name: DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF 5
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6182964
• MDR Text Key: 63071308
• Report Number: 3003418325-2016-00029
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 206320
• Device Lot Number: N5L0024X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• 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