MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS GEM MICROVASCULAR ANASTOMOTIC COUPLER; DEVICE,ANASTOMOTIC,MICROVASCULAR

Model Number GEM2753

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A supplemental report will be submitted upon completion of the returned product evaluation.

Event Description

It was reported that a gem 2.0mm coupler had a bent pin.The coupler ring was adequately removed from the vein and the anastomosis was completed with another coupler.This occurred during an unspecified surgery.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Aware date 12/21/2017, based on completed evaluation (b)(4) a device history record review was completed.No irregularities were found when reviewing supplier records.Ring separation testing was competed at the supplier with passing results.100% functional alignment testing was performed on each device during the manufacturing process.In addition, 100% visual inspection for broken or missing parts was performed.Ring retention testing was completed at incoming inspection with passing results.The released product met specification.Two 2.5mm gem coupler wing jaws were returned for evaluation.No coupler rings were returned.One device has a broken hinge.The other is normal.No functional testing was performed as the device has a broken hinge.The allegation of the coupler not closing properly cannot be refuted.Evaluation of the returned device confirms that the device is broken.The broken hinge can allow the wing jaw to rotate past the hinge stop tab.A broken coupler wing jaw renders the device nonfunctional.It is unknown how the device was handled prior to the event.The surgeon detected the device defect and completed the anastomosis with a new coupler.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Type of Device: DEVICE,ANASTOMOTIC,MICROVASCULAR
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7049746
• MDR Text Key: 93070074
• Report Number: 1416980-2017-09246
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

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: 05/04/2020
• Device Model Number: GEM2753
• Device Catalogue Number: 511100250010
• Device Lot Number: SP17F261236925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• 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