MAUDE Adverse Event Report: SYNTHES SELZACH 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE; NAIL, FIXATION, BONE

Catalog Number 04.004.452S

Device Problem Difficult to Remove (1528)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier was not available for reporting.Although requested, additional event and patient information have not been received as of the submission date of this report.(b)(4).Unknown.The nail had been implanted on an unknown date approximately 18 months prior to the (b)(6) 2016.It is unknown if the subject device will be returned to the synthes manufacturer for evaluation.(b)(6).(b)(4).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition.No non-conformances were generated during the production or sterilization of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2016 it was impossible to remove the nail.The nail was initially implanted on an unknown date approximately 18 months prior to the (b)(6) 2016 surgery to treat a fracture.The patient's activity level is reportedly high.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Updated information via operative notes: original procedure: the patient was originally admitted to the hospital for direct trauma to the left leg with no motor or sensory deficit.The calf was notably soft, showing no signs of compartment syndrome.A closed, central-medullary nailing procedure with distal locking was performed on (b)(6) 2014.The post-operative plan was to rehabilitate the knee with supported weight bearing and removal the nail two (2) years after fracture union.Scheduled revision/explant procedure: on (b)(6) 2016, the patient returned to the operating room for removal of the expert tibia nail via closed, antegrade osteosynthesiss.Prior to the procedure, the surgeon noted that the initial fracture had achieved union and maintained anterior/posterior and lateral axes.During the procedure, complications were encountered (as initially reported) preventing removal of the nail.The surgeon attempted extraction for three (3) hours, but was unsuccessful.

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5634627
• MDR Text Key: 44510414
• Report Number: 3000270450-2016-10111
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040762
• 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
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 04.004.452S
• Device Lot Number: 8542799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 70