MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.158S

Device Problem Fitting Problem (2183)

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

Event Date 10/15/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient weight not provided for reporting.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Concomitant devices reported: tfna screw 115 mm - sterile, part #-04.038.115s, lot #-7992346, quantity (1).Tfna helical blade 115 mm.Sterile, part #-04.038.315s, quantity (1).Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 24-jun-2016, expiration date: 31-may-2026.Part #: 04.037.158s, lot#: h414393 (sterile) - 11 mm/130 deg ti cann tfna 380 mm/right- sterile.Qty.5.Inspection sheet for in-process/inspect dimensional/final ns063045 rev: k and inspection sheet - tfna assembly inspection ns067861 rev: b met inspection acceptance criteria.Component parts reviewed and it meet specification: 04.037.942.2 - lock prong 130 degree, tfna bp-55 lot ¿ l415705, 04.037.912.4 - wave spring, shim ended bp-55 lot ¿ h316267, 04.037.912.3 - tfna lock drive bp-58 lot ¿ h407579, (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.(b)(4)(ethicon (abq)), ¿sterility documentation was reviewed and determined to be conforming.¿ if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during an initial right femur surgery on (b)(6) 2017, the set screw interlocking mechanism inside the nail was discovered to be already advanced.This inhibited the ability of the surgeon to implant the helical blade through the nail.The helical blade was not going through the nail.The surgeon then removed the helical blade and used a lag screw from another set in place of the helical blade.The surgeon had a similar experience with the locking mechanism of the nail while trying to implant the lag screw.The surgeon then loosened the locking mechanism of the nail and the lag screw was able to advance into the bone without any further incident.This caused a surgical delay of approximately 20 minutes.The surgery was completed successfully with no harm to the patient.The helical blade was disposed of at the hospital.The lag screw and the nail remain inside the patient.There was no fragmentation or any broken pieces to the devices.None of the devices will be returning to synthes.This complaint has 1 device.Concomitant devices reported: tfna screw 115 mm - sterile, part #-04.038.115s, lot #-7992346, quantity (1).Tfna helical blade 115 mm.Sterile, part #-04.038.315s, quantity (1).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.

• Brand Name: 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7010738
• MDR Text Key: 92599088
• Report Number: 1719045-2017-11161
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2017

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 Catalogue Number: 04.037.158S
• Device Lot Number: H414393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR