MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE RATCHET BIPASS SUTURE PASSER; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, it states, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-03612 / 03613).

Event Description

It was noted that during the testing of this product outside of a procedure, the disposable nitinol wire would not pass easily through the suture passer.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of the device history records for pn 902099 ln 106590 identified no deviations or anomalies.Product was visually examined and found to have very little wear externally.The product was then function tested with the bipass disposable nitinol that was returned and there was significant resistance felt when attempting to push the nitinol through the device therefore, confirming the complaint.A new bipass disposable nitinol was requisitioned from the shelf and the device was again function tested.The same resistance was felt with this pusher as with the last one.Therefore, it was determined that the issue was the bipass suture punch and not the nitinol.It cannot be determined why there was significant resistance felt when trying to pass the nitinol through the suture punch.It is possible that repetitive use has worn down the inner barrel of the punch but this cannot be confirmed.A conclusive root cause could not be determined.Further investigation into this issue is ongoing and if additional information is received, a follow-up report will be submitted to the fda.

Manufacturer Narrative

Correction: date returned to manufacturer was corrected upon receiving the tracking number.

• Brand Name: RATCHET BIPASS SUTURE PASSER
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5949560
• MDR Text Key: 54683342
• Report Number: 0001825034-2016-03612
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 902099
• Device Lot Number: 106590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1