MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER

Catalog Number 228143

Device Problems Activation, Positioning or Separation Problem (2906); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4) - incomplete.The expiration date is not currently available.Associated medwatches: 1221934-2018-54469, 1221934-2018-54470, 1221934-2018-54472.

Event Description

It was reported during shoulder arthroscopy procedure on (b)(6) 2018, second implant could not be fired.The depth stop restricted the opening for the second implant.They opened a second omnispan gun which had the same problem.Only the third omnispan worked.The surgery took more time, they had to open a new omnispan gun and it frustrated the surgeon.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.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 was received and inspected visually and functionally.Visual observation revealed only a slight bend in the pusher rod on the device.When tested for its functionality, both triggers functioned properly when pulled on their own without a needle attached to the device.Additionally, a 0 degree needle was loaded onto the applier and both implants were deployed successfully.The applier works as intended and we cannot confirm the reported complaint.Per qlik query executed, no nonconformances were identified for this part-lot number combination.Furthermore, a review into the depuy synthes mitek complaints system revealed two dissimilar complaints for this lot of devices.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.Udi: (b)(4).Associated medwatch report number: 1221934-2018-54469, 1221934-2018-54470, 1221934-2018-54472.

• Brand Name: MENISCAL DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7774958
• MDR Text Key: 117168471
• Report Number: 1221934-2018-54471
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228143
• Device Lot Number: L717622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Date Manufacturer Received: 10/10/2018
• Patient Sequence Number: 1