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

Catalog Number 228151

Device Problem Positioning Failure (1158)

Patient Problem Not Applicable (3189)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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).The expiration date is unknown.

Event Description

It was reported by the affiliate via complaint submission tool that during a meniscal repair the truespan 0 degree peek fired the first implant but the second implant was not able to be fired, at least 2 or 3 attempts were made and than the device had to be changed.The same issue occurred with the truespan 12 degree peek and again the device had to be changed.The third device was able to work fine.As per the surgeon the implant was not used at an incorrect angle.No patient consequence has been reported, however there was a 10 minutes surgical delay.

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.Investigation summary: the complaint device was received and evaluated.Visual observation reveals one implant attached to suture logged in the silicone sleeve which appears to be intact.The needle was found to be deformed/bent downward.Therefore, this complaint can be confirmed.With the information provided we cannot determine a definitive root cause.However, it is possible that excessive force applied on the needle during the case could have caused the second implant not to deploy.Furthermore, a manufacturing record evaluation was performed for the finished device lot number 3l68980, and no non-conformances related to the reported complaint condition were identified.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).The expiration date is unknown.

• 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
• MDR Report Key: 9331268
• MDR Text Key: 208347272
• Report Number: 1221934-2019-59560
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228151
• Device Lot Number: 3L68980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 01/17/2020
• Patient Sequence Number: 1