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

Catalog Number 228151

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

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.Udi: (b)(4) ¿ incomplete.The expiration date is not currently available.

Event Description

It was reported by the sales rep via phone that during a meniscal repair the surgeon who has great experience with using truespan was training another surgeon on using the device.The sales rep stated that when using their first truespan 12 degree peek (lot number l642085), the surgeon in training was going into the joint space with downward force at about 2 inches before the needle where the white plastic sheath meets bent approximately half an inch before deploying the implant.The second truespan 12 degree peek (lot number l668636) deployed the first implant perfectly and when the surgeon in training turned the device on angle forcedly a loud mechanical click was heard not the normal click the device is intended to do.The sales rep stated that the surgeon when he pulled the trigger and pulled out of the joint space the second implant had unloaded off the device.The second implant never implanted in the meniscus and was cut at the suture with no damage to the meniscus.The first implant was left in unused and the procedure was completed with a third like device with no harm to the patient but there was a two minute delay to open a new device each time.The sales rep stated that she had a conversation with the surgeon (who has the experience using the device) regarding the issues that occurred after the procedure, he stated that the other surgeon's technique was off when using the devices and may have twerked the device each time too much.She also stated that the surgeon (with experience) mentioned he loves truespan.The devices were both discarded by the customer but attached to the complaint is a photo of the bent device.

Manufacturer Narrative

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.The exp date was reported as unknown in the initial report and has been updated as 10/31/2020.Therefore, udi: (b)(4).The manufacturing name was reported as depuy mitek llc us in the initial report and has been updated as medos international sã rl.Address have been updated accordingly.The complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle 2400 ; SZ 2400
• MDR Report Key: 7481733
• MDR Text Key: 107357777
• Report Number: 1221934-2018-50556
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 228151
• Device Lot Number: L642085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1