MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL ORTHOCORD VIOLET W/MO7 TAPRNDL * PK/12; POLYDIOXANONE SUTURE

Model Number 223104

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Not Applicable (3189)

Event Date 03/10/2020

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)(6).Udi: (b)(4).

Event Description

It was reported by affiliate via complaint submission tool that the rgdloop adjustable long the white thread in charge of raising the graft broke after tensioning the graft, in addition the orthocord violet w/mo7 taprndl pk/12 the plate that holds the graft is brought and cortical fixation is lost.No patient consequences, there is a surgical delay of 45 minutes reported.The device is available to be returned for evaluation.

Manufacturer Narrative

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.H10 additional narrative: correction: d10, h3, h6, h10: it was inadvertently reported on the previous report that the device was returned for investigation; however, upon complaint review, it was determined that the device was not returned as it remained in the graft of the patient.Therefore, the investigation summary is as follows: investigation summary
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> the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (5l77409), and no non-conformances 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.Device history lot
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> a manufacturing record evaluation was performed for the finished device lot number (5l77409), and no non-conformances were identified.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: 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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: POLYDIOXANONE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9879469
• MDR Text Key: 205461253
• Report Number: 1221934-2020-00980
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10886705008759
• UDI-Public: 10886705008759
• Combination Product (y/n): N
• PMA/PMN Number: K040004
• 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: 03/11/2020

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: 07/31/2022
• Device Model Number: 223104
• Device Catalogue Number: 223104
• Device Lot Number: 5L77409
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 04/02/2020; 05/14/2020
• Supplement Dates FDA Received: 04/03/2020; 05/14/2020
• Patient Sequence Number: 1
• Patient Weight: 60