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

Catalog Number 228143

Device Problems Break (1069); Material Separation (1562); Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189); No Code Available (3191)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Associated medwatch # 1221934-2016-10075, 1221934-2016-10076.(b)(4).

Event Description

The sales rep reported that during an am acl repair that the flipping suture on the rigidloop adjustable cortical implant long broke after the button was flipped.The surgeon confirmed with x-rays that the button was flipped and sitting on the bone correctly.The sales rep reported that the suture broke inside the joint space right at the button and pulled out.The surgeon was pulling on the suture with his hands when the suture broke and no other rigidloop was needed to secure the fixation.The sales rep reported that the graph size was 10 1/2 and tunnel was 10 1/2 for both tibial and femoral.During the same procedure the surgeon was doing a meniscal repair and using the omnispan meniscal applier when the needle bent on the second deployment of the omnispan meniscal repair system 0 degree needle.The surgeon cut the suture leaving the 1st implant secured within the meniscus.The surgeon then used a 2nd omnispan meniscal repair system 0 degree needle which also only deployed the 1st implant and then did not fire the second implant.Again the surgeon cut the suture leaving the 1st implant secured within the meniscus.The surgeon completed the procedure with another like gun and a 3rd omnispan meniscal repair 0 degree needle placed adjacent to the first two implants.The sales rep reported that there were no patient consequences but there was a ten minute delay in the procedure.

Manufacturer Narrative

The complaint device is not available for a physical evaluation and no further information is available to determine a root cause for this failure.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints 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.(b)(4).

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not available for a physical evaluation and no further information is available to determine a root cause for this failure.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints 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.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device is not available for a physical evaluation and no further information is available to determine a root cause for this failure.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints 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).

• Brand Name: MENISCAL APPLIER, OMNISPAN
• Type of Device: MENISCAL INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 5482359
• MDR Text Key: 39738635
• Report Number: 1221934-2016-10077
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 228143
• Device Lot Number: 3841004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2016
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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