MAUDE Adverse Event Report: DEROYAL INDUSTRIES KNEE ARTHROSCOPY PACK; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 89-8275

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2014

Event Type  malfunction  

Event Description

Packs were found to have holes in outer plastic bag.Also, holes were found on outer blue wrap of packs even without puncture mark on plastic bag.One pack was being opened for case when holes were noticed.

Manufacturer Narrative

Investigation findings: the qfi report was reviewed to obtain the sales and similar complaint info deroyal has sold (b)(6) cases of the finished good from 08/2013 to 2014.There have been no previous reports of this mature prior to the customer filing three separate reports.When a report is received identifying a hole is present within the backtable cover/sterilization pouch, deroyal attempts to identify when and how the damage occurred.The sample was returned for eval to assist in the investigation process.It was confirmed that damage was present on the backtable cover and sterilization pouch.The review identified the damage to the product occurred due to friction between the platform tray edge; backtable cover; and sterilization pouch.The work order was reviewed and it was confirmed the product does not contain a tray protector.In an effort to reduce the reported issue from occurring again due to the root cause findings, a request was submitted to the tray engineering department to add a tray protector to the device.In addition, the qc complaint specialist has followed up with the deroyal sales rep, on 07/25/2014, in reference to the info contained within the text: "the personnel at the hospital feel that the outer plastic bag has changed and is not the same quality as previously.If it has changed, please change back to previous version the hospital has had a recent spike in knee arthroscopy cases and is wondering if our packs could be a cause and they did not notice other holes previously".It was identified from the deroyal sales rep that an increase of infection cases has been identified within the hospital following knee arthroscopy procedures.This info was provided to deroyal's regulatory department on 07/25/2014.As part of the investigation process, the eco for a part screen was reviewed within jde.There have been no indications of a sterilization pouch change for the device.The qc complaint specialist contacted the pouch vendor for conformation that no changes have been made to the specs/gauge requirements.Gauge testing is performed as part of the vendor's mfg process.The material is tested during the extruding process and after it is collected on the master roll refer to the spec letter attachment.In addition, no evidence between the increase in the hospital infection reports and the deroyal product could be identified.All of the reports received indicate the issues were discovered prior to use and pt contact.It is unk as to what environmental factors and alternate vendor supplied products that are present at the hospital which could have contributed to their increasing infection reports.Correction: a replacement has been provided on order # (b)(4).Root cause analysis: the report has been determined to be random report for the finished good due to friction between the platform tray: backtable cover; and sterilization pouch.This friction could have occurred during the handling process, which includes transport of the device.Correction action and/or systemic correction action taken: eco (b)(4) was initiated to add a tray protector to the bom.If action not taken, indicate reason why and by who: preventive action: a preventive action has not been taken.No further info available at this time.Will provide follow ups if add'l info becomes available.

• Brand Name: KNEE ARTHROSCOPY PACK
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES; 1501 east central ave.; lafollette TN 37766
• Manufacturer Contact: 200 debush lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 4059586
• MDR Text Key: 4866405
• Report Number: 3005011024-2014-00010
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2014

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 Expiration Date: 12/30/2018
• Device Catalogue Number: 89-8275
• Device Lot Number: 34875219
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/21/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention