MAUDE Adverse Event Report: DEPUY MITEK MENISCAL APPLIER, OMNISPAN; MITEK MENISCAL INSTRUMENTS

Catalog Number 228143

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Tissue Damage (2104)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot expiration date is currently not available.

Event Description

During knee surgery device staples twice despite that physician shot only once.Staples have been removed from patient body.Surgery delay not more than 30 minutes.Procedure was completed with same like product.

Manufacturer Narrative

The complaint device was received and evaluated.Visual observation of the applier revealed the distal end of the main pusher rod (gray trigger) was significantly bent downward, which is typical of aggressively removing the needle following use.Moreover, there is a lot of tissue debris and stains on the main rod.The needle was not returned but if the needle was over inserted this would cause the silicon sleeve to push back which could potentially cause both implants to fire at the same time.Other than this possibility, a root cause for the user to have experienced this failure cannot be determined.This complaint can be confirmed.A batch record review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.Based on the overall complaint rate and customer impact, at this point in time, no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).

• Brand Name: MENISCAL APPLIER, OMNISPAN
• Type of Device: MITEK MENISCAL INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6227863
• MDR Text Key: 64009686
• Report Number: 1221934-2017-10005
• Device Sequence Number: 1
• Product Code: GEF
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 228143
• Device Lot Number: 3922589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2016
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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): Other