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

Catalog Number 228151

Device Problems Positioning Failure (1158); Migration or Expulsion of Device (1395)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

(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).

Event Description

It was reported by the sales rep via phone that during a meniscal repair procedure the second implant on their truespan peek 12 degree pulled out when the surgeon was tightening.They removed the first implant with no issue.When trying to use their second truesapn peek 12 degree, the device made a strange noise when pressing the trigger and the first implant would not deploy.The procedure was completed by using a competitor's device with no patient harm but there was a seven minute surgical delay to the case.The implants were discarded from the first gun but the gun itself and the second device will be returning for evaluation.

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 device was received and evaluated.The red trigger lever does not function.The spring or handle are damaged inside of the housing and the trigger doesn¿t move the push rod.The spring is not functioning and doesn¿t return the handle to its proper position.There were no anomalies noted on the distal end of the device.The sleeve was removed from the shaft and both of the implants and the suture are in the proper location.The probable root cause of this failure is an excessive force was applied to the trigger handle.This causes the spring that is used to return the handle to its original position to have fallen off the post that secures it.This complaint can be confirmed.No nonconformances were identified for this part number, lot number combination.Review conducted per qlik query executed on 11/4/2019.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.Review conducted per qlik query executed on 11/4/2019.Outcomes attributed to adverse event checked; intervention required.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 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: 9166379
• MDR Text Key: 168901053
• Report Number: 1221934-2019-58830
• 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
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 228151
• Device Lot Number: 1L49205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 11/04/2019
• Patient Sequence Number: 1