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

Catalog Number 228143

Device Problems Detachment Of Device Component (1104); Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2017

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.(b)(4).

Event Description

The affiliate reported via email screw loose.For the 228141, two knots popped out together during first firing, and hung on the meniscus directly.For the 228143, the screw fell out when open the safety cover.Changed with same like product to finish the operation.Additional information received via email from the affiliate on 9-20-17.You can see from the attached photo clearly that the screw is missing which lead bar is away from the handle.The double-deployment did not result in surgical delay of greater than 30 minutes or an inability to complete the procedure as intended.The procedure was completed.Alternatives were readily available there were no procedural or patient anatomy factors which may have contributed to the breakage.There is no surgical intervention planned.Nothing was left in the patient.If not, how were the implants removed?.Na.There is no report on patient¿s injury.Additional information received via email from the affiliate on 10-9-17.Both implants deployed at the same time.It is unknown if/how the implants were removed.There is no report on patient¿s injury or tissue damage.

Manufacturer Narrative

The complaint device was discarded by the customer therefore, device is not available for a physical evaluation.This complaint is not confirmed.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.Although pictures were provided showing the ¿screw¿ is missing from the safety cover hinge a specific root cause for this type failure cannot be determined.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Further, a review into the depuy mitek complaints system revealed six dissimilar complaints for this lot of devices that were released to distribution.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: (b)(4).Associated medwatch [mfr # 1221934 -2017-10583].

• Brand Name: MENISCAL APPLIER, OMNISPAN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• 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: 6944501
• MDR Text Key: 89840184
• Report Number: 1221934-2017-10582
• 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: 09/15/2017,10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 228143
• Device Lot Number: L252388
• 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: 09/15/2017
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1