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 05/23/2017

Event Type  Injury  

Manufacturer Narrative

The complaint device is not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A dhr review has been conducted and the results indicate that this batch of product was processed without any incidents and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed one dissimilar and one similar complaint for this lot of devices that were released to distribution.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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.Udi: (b)(4).Associated medwatch: 1221934-2017-10313.

Event Description

Affiliate reported via email during a meniscal repair, the rep was not present during the case but was told the surgeon deployed the first back stop and when tried to deploy the second backstop it jammed and failed to deploy.Action taken to manage problem menisectomy had to be performed.Adverse event report to patient as menisectomy was required.Additional information received via email from the affiliate on 5-31-17: delay to procedure is 10 minutes.Rep was informed that the surgeon performed a partial menisectomy as the first backstop had deployed and the second one jammed.As the first backstop had deployed he had to cut it out of the meniscus.With a backstop already deployed there is no other device to rectify the repair.

• 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: 6658653
• MDR Text Key: 78126666
• Report Number: 1221934-2017-10314
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 228143
• Device Lot Number: 3914599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2017
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• 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