MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228151

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint devices were not returned and they were discarded by the customer, therefore unavailable for a physical evaluation.We cannot discern a root cause for the reported failure mode.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for these two lots of devices that were released to distribution.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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

This is report 1 of 2 for the same event.It was reported by the sales rep that the first implant on two of the customer's true span 12 degree peeks were deployed prior to using the devices during a meniscal repair.According to the reporter, the implant deployed prior to being used on the patient.It was reported that nothing was needed to be removed from the patient.It was further reported that the surgeon was introducing the 1st complaint device into the patient, when the distal tip came into scope view, the surgeon noted that the 1st implant had already been deployed.The surgeon had not pulled the trigger on the device.The device had not been introduced into the meniscus, and was removed as soon as the surgeon saw the deployed implant hanging off the device.A 2nd like device was passed to the surgeon and as he introduced it into the patient he noticed the first implant had already been deployed like the 1st device.This device was also removed from the patient prior to be introduced to the meniscus.The sales rep stated there was discussion in the room as the 2nd device was being introduced into the patient on whether someone at the back table may have pulled the trigger prior to passing the device to the surgeon.The sales rep stated while there was no confirmation, there is some belief that the trigger may have been pulled on the two devices prior to it being passed to the surgeon for use.There were no patient consequences or delays.The case was completed with another like device.The devices were discarded by the customer.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL S RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8282324
• MDR Text Key: 136281822
• Report Number: 1221934-2019-56167
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 228151
• Device Lot Number: L344759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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