MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 0 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228150

Device Problems Positioning Failure (1158); Mechanical Jam (2983)

Patient Problem Not Applicable (3189)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Initial reporter phone number: (b)(6).Udi: (b)(4).

Event Description

It was reported by the affiliate via email that 3 truespan 0 degree peek failed.The first 2 jammed and wouldn't deploy the first implant each time.The third one deployed the two implants as designed but then the suture broke during tightening.The procedure has been completed by using a replacement device.15 minute delay to the procedure.No adverse event to patient.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

Event Description

Updated: the procedure was an arthroscopic procedure.The break occurred mid-way down the suture away from the implant.The suture was not in contact with the instrument; special attention was given to not damage the suture with the needle of the truespan gun.No suture passer was used in the procedure.The suture color was unknown.A mitek sliding knot pusher was used as the suture cutter in the procedure.It was noted the surgeon used the proper suture procedure.The case was completed successfully.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A non-conformance search was performed for this product code 228150, lot #2l16300 combination and no non-conformances were identified.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Device history no nonconformances were identified for this part number, lot number combination per qlik query executed on 9/5/2019.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.

• Brand Name: TRUESPAN 0 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: 9145493
• MDR Text Key: 205365598
• Report Number: 1221934-2019-58752
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026005
• UDI-Public: 10886705026005
• 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,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 228150
• Device Lot Number: 2L16300
• Date Manufacturer Received: 12/05/2019
• Patient Sequence Number: 1