MAUDE Adverse Event Report: DEPUY MITEK LLC US ORTHOCORD VIOLET W/MO7 TAPRNDL * PK/12; POLYDIOXANONE SUTURE

Catalog Number	223104
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device is not available for a physical evaluation.This complaint cannot be confirmed.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.The dhr review indicated that these was processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in the future, this file will be re-opened and a thorough investigation will be performed.Depuy 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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the orthocord violet w/mo7 taprndl, pk/12 suture device broke at the final base of the graft when it was pulled.According to the reporter, the event occurred when the miracle interference screw was to be placed to prepare the graft.There was no delay in the surgical procedure as an identical spare device was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional 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 manufacture date: the device manufacture date was inadvertently missed in the initial report and has been updated as 1/7/2017.If additional information should become available, a supplemental medwatch will be submitted accordingly.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

• Common Device Name: POLYDIOXANONE SUTURE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8281005
• Report Number: 1221934-2018-53946
• Device Sequence Number: 11167052
• Product Code: NEW
• UDI-Device Identifier: 10886705008759
• UDI-Public: 10886705008759
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 223104
• Device Lot Number: KP2947
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR