MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS OCTOBASE SUTURE INSERT; RETRACTOR

Model Number 28707

Device Problem Component Missing (2306)

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

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, visual inspection of the returned retractor inserts and suture holder revealed two suture holders missing from the device.One loose suture holder was returned.After the device was cleaned, damage was observed to the insert near the empty space of the missing suture holder.Medtronic's investigation is in progress.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that after completion of a procedure, the customer observed that two of the suture holders from the retractor insert were missing.One was found in the garbage, but the second was not located.Fluoroscopy did not find the suture holder within the patient's body.There have been no adverse patient effects as a result of the event.

Manufacturer Narrative

Conclusion: after review at medtronic and its supplier, the complaint of missing suture cams was confirmed.One insert had a white mark present where the suture cam would be seated, which appeared to be a stress mark consistent with damage to the product.The returned suture cam did not appear to have any damage and would be seated in the area of the insert where the stress mark was present.The second insert did not appear to have damage and the associated suture cam was not discovered by the customer, therefore was not returned.The suggested root cause for the first insert is damage to the product, causing the suture cam to be displaced from the suture holder.For the second suture insert and cam, the root cause could not be conclusively determined.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.Medtronic will continue to monitor for future occurrences and trends.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the customer has stated that both suture holders were attached to the retractor prior to use and that the suture holders were attached to the retractor during the procedure.Conclusion: after additional review at medtronic and its supplier it has been concluded the suture cams (holders) were not seated properly in the insert.If information is provided in the future, a supplemental report will be issued.

• Brand Name: OCTOBASE SUTURE INSERT
• Type of Device: RETRACTOR
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6730292
• MDR Text Key: 80808310
• Report Number: 2184009-2017-00025
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 28707
• Device Catalogue Number: 28707
• Device Lot Number: 2017011220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1