MAUDE Adverse Event Report: BIOMET ORTHOPEDICS JGRKNT 1.0MM MINI 3-0 NDLS; FASTENER, FIXATION

Model Number N/A

Device Problems Break (1069); Fracture (1260); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 02/07/2014

Event Type  Injury  

Event Description

It was reported that patient underwent proximal interphalangeal joint (pip) procedure on (b)(6) 2014.During the procedure, the surgeon attempted to insert juggerknot mini in the first hole drilled; however, the sleeve was stuck and juggerknot would not work.The surgeon opened another juggerknot mini and attempted to insert; however, the sleeve did not work again and the bone fractured due to a hard insertion.The surgeon made another hole and attempted to insert another juggerknot mini; however, bone hole was broken due to the sleeve sticking.The surgeon stopped using the juggerknot mini and implanted bionic bone and a k-wire in the fractured part.There was a delay in the procedure of approximately 45 minutes due to the event.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur.Additional units attempted for implantation: catalog number 912076, lot number 076850, manufacture date: aug 20, 2013, expiration date: aug 31, 2018.Catalog number: 912082, lot number: 608390, manufacture date: oct 9, 2013, expiration date: sep 30, 2018.Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, the sleeves were able to be manipulated by hand, therefore the root cause was determined to be due to surgeon preference.(b)(4) has been addressed for the event.

Manufacturer Narrative

This follow-up report is being filed to relay additional information.This report is number 1 of 3 mdr's filed for the same event (reference 1825034-2014-01673 & 06079 / 06080).

Event Description

It was reported that patient underwent proximal interphalangeal joint procedure on (b)(6) 2014.During the procedure, the surgeon attempted to insert a juggerknot mini in the first hole drilled; however, the sleeve was stuck and juggerknot would not work.A second juggerknot mini of the same lot was attempted but was unsuccessful.The surgeon opened another juggerknot mini and attempted to insert; however, the sleeve did not work again and the bone fractured due to a hard insertion.The surgeon made another hole and attempted to insert another juggerknot mini; however, bone hole was broken due to the sleeve sticking.The surgeon stopped using the juggerknot mini and implanted bionic bone and a k-wire in the fractured part.There was a delay in the procedure of approximately 45 minutes due to the event.

• Brand Name: JGRKNT 1.0MM MINI 3-0 NDLS
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3676418
• MDR Text Key: 17279350
• Report Number: 0001825034-2014-01673
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 912082
• Device Lot Number: 809940
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 03/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/01/2014; 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention