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

Catalog Number 228150

Device Problem Positioning Failure (1158)

Patient Problem Not Applicable (3189)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by the sales rep via cst that during a meniscal repair procedure the truespan meniscal repair peek 12 degree deployed the first and second implants, but while tensioning the suture, the second implant pulled out.The sales rep stated the implant did not deploy the full depth that was required.The truespan meniscal repair peek 0 degree trigger was being squeezed to deploy the first implant when the trigger collapsed and broke.The sales rep stated this did not allow either implant to deploy.The case was completed with another company's implant with no patient harm, but a seven to ten minute delay to remove and discard the implants.

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.No non-conformances were identified for this part (228150) - lot number (l705665) combination.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Date of report/date received by manufacturer: initially reported as march 08, 2019 but should have been march 07, 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 SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8489166
• MDR Text Key: 141201489
• Report Number: 1221934-2019-56779
• 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
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

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 Expiration Date: 12/31/2020
• Device Catalogue Number: 228150
• Device Lot Number: L705665
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 04/26/2019
• Patient Sequence Number: 1