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

Catalog Number 228143

Device Problem Positioning Failure (1158)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

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.(b)(4).

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.

Manufacturer Narrative

There were two omnispan gun complaint devices reported for this complaint event.The complaint devices were reported to be from lot numbers 3833501 and 3848896, however there was no association as to which lot number belonged to which complaint device.Evaluation of both returned devices revealed a bent push rod.There are no lot numbers on the devices which makes it impossible to determine which one was the complaint device which had deployment issues and which device was functional during the case but reported to have a bent spring after use.Device 1: one complaint device was reported to have made a squeaking noise and did not deploy the second implant on two occasions.There was no reported physical damage to it.The complaint device was received and evaluated.Visual observation for the applier gun revealed the main push rod (lower rod) on the applier was bent.A bent push rod can cause difficulty in deployment of the implant; however, it was reported that the device was straight during and after use in the procedure and no other anomalies were noted on the returned device.Therefore, the complaint of the applier not deploying the second implant cannot be confirmed and a root cause for the issue that the user experienced cannot be determined.The damage to the push rod that was observed on the returned device likely occurred at some point during transportation between the customer to the decontamination unit or on the way to our facility.There were two lot numbers provided for the two complaint devices, however they were not associated to a particular complaint device.Device history record reviews were conducted for both lots reported to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that both batches of products were processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.For the complaint of the second implant not deploying, a review of the depuy synthes mitek complaint system for both reported complaint device lot numbers revealed one other similar and five other dissimilar complaints.At this point in time, no corrective action is required and 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.Device lot number cannot be identified precisely with respect to the complainant device.It's one of the below two udi's: (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: 6766133
• MDR Text Key: 82063391
• Report Number: 1221934-2017-10403
• 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: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/01/2017
• 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: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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