MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ DISPOSABLE WRENCH; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C5602

Device Problems Hole In Material (1293); Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2016

Event Type  malfunction  

Event Description

On (b)(6) 2016, during the incoming inspection of products by the distributor it was discovered that the c5602 cusa excel 36khz disposable wrench had a hole in the package.There was no patient involvement thus no injury or delay in surgery.

Manufacturer Narrative

Integra has completed their internal investigation on 01 jul 2016.The product was not returned for evaluation.However, the reporting facility provided a picture of the complaint unit which shows a hole in the tyvek lid.The device history record (dhr) of fg lot 1161352 was reviewed and no anomalies were found during the packaging process.The dhr review was focused on the packaging and sterilization process.No similar complaints related to ¿a hole on the package¿ have been reported during the past twenty four (24) months on the cusa wrench family.Approximately (b)(4) units of cusa wrench products have been shipped for sales purposes since (b)(6) 2014 until (b)(6)2016, resulting in a complaint occurrence rate of approximately (b)(4).This was determined by dividing the number of complaints in this category ((b)(4)) by the number of units shipped for sales purposes of the cusa excel units.Conclusion: the reported condition was confirmed based on the picture provided by the reporting facility ((b)(4)).However, a definite root cause for the condition described as ¿at our incoming inspection, we found a hole on the package¿ could not be determined at this time.The potential root cause may be related to the handling of the product at the distribution center.No assignable causes that could be associated to the manufacturing process were determined based on the review of the dhr, capa's and ncr's history.In addition, process controls are in place to detect the reported condition.Awareness training was provided to the manufacturing and quality personnel emphasizing the importance of following the packaging and inspection procedures.

Manufacturer Narrative

Integra has completed their internal investigation on 09/21/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: one (1) unit from catalog c5602, cusa excel 36 khz disposable wrench corresponding to fg lot # 1161352 was received for evaluation.Returned unit was received in the original package.The visual evaluation of the device identified a hole in the tyvek lid.The evaluation of the complaint unit confirms the reported condition since it was observed a hole in the tyvek lid of the returned unit.The device history record (dhr) of fg lot 1161352 was reviewed and no anomalies were found during the packaging process.The dhr review was focused on the packaging and sterilization process.The fg lot # 1161352 was released for distribution purpose on 04/13/16 in compliance with the product specifications and integra requirements.No anomaly or discrepancy was reported during the packaging or sterilization processes of the fg lot that could be related to the reported condition.No similar complaints related to ¿a hole on the package¿ have been reported during the past twenty four (24) months on the cusa wrench family.Approximately (b)(4) units of cusa wrench products have been shipped for sales purposes since 06/03/14 until 06/03/16, resulting in a complaint occurrence rate of approximately (b)(4).Conclusion: the reported condition described as ¿at our incoming inspection, we found a hole on the package¿ was confirmed with the returned unit.Manufacturing process of cusa wrench was inspected.Manufacturing personnel only manipulate the product for inspection of particles, clean the wrench with 100% isopropyl alcohol using a lint free wipe, place the wrench into a tray and seal it.There is no sharp objects in work stations of cusa wrench c5602 and no operation was found in which a hole in the tyvek lid could be possible.The potential root cause may be related to the handling of the product at the distribution center.No assignable causes that could be associated to the manufacturing process were determined based on the review of the dhr, capa's and ncr's history.In addition, process controls are in place to detect the reported condition.

• Brand Name: CUSA EXCEL 36KHZ DISPOSABLE WRENCH
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5730230
• MDR Text Key: 48502063
• Report Number: 3006697299-2016-00145
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: C5602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• 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