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

Model Number 228151

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Occupation: initial reporter is company sales representative.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019 during meniskus refixation procedure, the devices did not fire.The procedure was completed with a second device.There was approximately five to ten minutes of surgical delay.There was no harm to the patient.This is report 2 of 2 for (b)(4).

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated.The suture and implants were not in the gun or returned with the device.Visual inspection reveals no anomalies on the device.The sleeve was removed from the device and the clear tubing that secures the implants was in the proper location and no anomalies were observed on the distal end of the gun.The trigger was pulled, and the device functions as intended.We cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.No nonconformances were identified for this part number (228151), lot number (2l44749) combination.Review conducted per qlik query executed on 6/12/2019.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.Udi (b)(4).

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.Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Correction: udi: the udi was incorrectly reported on the previous report.The correct udi: (b)(4).Device code: upon complaint review, it was found that the device code was chosen incorrectly at intake; therefore, it has been updated from functional: jammed/seized to functional: will not release (failure to deploy).

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 additional information should become available, a supplemental medwatch will be submitted accordingly.Correction: udi: the udi was inadvertently missed on the initial report.Therefore udi: (b)(4).The exp date is currently unavailable.Additional information: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: TRUESPAN MENISCAL REPAIR SYSTEM PEEK 12 DEGREE
• 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: 8514876
• MDR Text Key: 144987244
• Report Number: 1221934-2019-56849
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: (01)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,Followup,Followup
• Report Date: 03/19/2019

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: 12/31/2021
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 2L44749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 04/18/2019; 05/23/2019; 06/12/2019
• Supplement Dates FDA Received: 05/07/2019; 05/30/2019; 06/13/2019
• Patient Sequence Number: 1