MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA SPIDER PLATE AND SCREWS; SPIDER LIMITED WRIST FUSION SYSTEM

Catalog Number XXX-SPIDER

Device Problems Component Missing (2306); Compatibility Problem (2960); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  malfunction  

Event Description

It was reported screws from a competitor's set were used to complete the procedure.It was reported the patient was on the table when the issue was discovered.The warehouse requested of the sales team a last minute switch of a spider implant kit.The kit returned to the warehouse from the sales team was a normal stainless steel kit.The kit provided to the sales team from the warehouse was a titanium spider set."hospital says 2.8mm 12 and 16 screws missing and no 2.4mm screws (as would be expected in the stainless version).Apparently these are not supplied with the ti kit for (b)(6)." it was reported the surgeon completed the surgery by using the screws from a competitor.The sales agent advised the hospital that the set they used for the procedure is titanium but they may have used stainless steel screws (to complete the procedure) - which is an incompatibility issue with regard to competitive screws and mixed materials.The sales team was not aware they were to receive a titanium set.No patient injury is reported.

Manufacturer Narrative

Integra has completed their internal investigation on march 6, 2017.The investigation included: methods: review of device history records, review of complaints history.Results: dhr review; the issue is a distribution-related issue.It is not related to the performance of the product.Complaints history; two year look back via text query reveals no other complaints for spider implants.Conclusion: based on the investigation performed by integra, the complaint reported is confirmed.It has been found out that there was a lack of precision in the name of the spider set recorded in the erp system which didn't allow to distinguish a set with stainless steel implants from a set with titanium implants.That led to a confusion during the shipment.Corrective actions have been defined to remediate the reported issue and are still in implementation step, monitored in the integra quality management system.

• Brand Name: SPIDER PLATE AND SCREWS
• Type of Device: SPIDER LIMITED WRIST FUSION SYSTEM
• 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: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5841352
• MDR Text Key: 52298693
• Report Number: 3004608878-2016-00202
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K990094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-SPIDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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