MAUDE Adverse Event Report: DEPUY MITEK UNK OMNISPAN; MITEK MENISCAL IMPLANTS

Catalog Number UNK OMNISPAN

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/04/2017

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.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.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required, and 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: unavailable.No product information is available.

Event Description

The affiliate reported via email during a meniscal repair, the surgeon deployed the first implant successfully, but when he went to deploy the second implant the omnispan meniscal deployment gun handle made a squeaking noise and did not deploy the second implant, it was still in the deployment gun.He pressed on the gray handle again and again and the implant would not deploy.They opened a second deployment gun and this deployed the anchors as per surgical technique, but when the scrub nurse went to put a new needle on, rep noticed the tip of the spring that offloads the implant was bent.They chose not to use this.They assessed the first gun again.The spring looked straight and it seemed to fire well when the gray handle was squeezed, the scrub nurse loaded another needle, but the same thing happened, the first implant deployed well and the second implant did not it was still in the needle.The surgeons technique looked correct.Could it be due to his strength when squeezing the deployment gun gray handle.There was no delay in the procedure.No ae to patient.Additional information from affiliate on 7-25-2017: all implants that deployed remained in the patient.As soon as i noticed the spring was bent, we opened a new gun.The first gun that jammed, was used for the last implant due to the 2nd gun having a bent spring.

• Brand Name: UNK OMNISPAN
• Type of Device: MITEK MENISCAL IMPLANTS
• 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: 6909714
• MDR Text Key: 87997127
• Report Number: 1221934-2017-10549
• Device Sequence Number: 1
• Product Code: HCF
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: UNKNOWN
• 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: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK OMNISPAN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 07/04/2017
• Date Manufacturer Received: 07/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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