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

Catalog Number 456.418S

Device Problem Component Missing (2306)

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

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).The locking mechanism was not present in the nail when attempting to lock the helical blade.The surgeon removed the construct, reamed the intramedullary canal one millimeter wider and implanted a slightly larger nail.Device history records review was conducted.The report indicates that the: part 456.418s; lot h302839.Manufacturing location: (b)(4).Manufacturing date: 23-feb-2017.Expiration date: 31-jan-2026.Part #: 456.418s, lot#: h302839 (sterile) - 11mm/130 deg ti cann troch fixation nail 380mm/right - sterile.Quantity 6.Component parts reviewed: 456.314.3 - trochanteric fixation nail lock driver tfn, bp 55, lot h129057 received from mark two engine.Quantity:(b)(4).Release to blank storage on 29-sep-2016.Inspection sheet for inspect dimensional/final meets specification.456.315.2 - trochanteric fixation nail lock 130 deg lock prong tfn, bp 58, (b)(4).Quantity:(b)(4).Inspection sheet for inspection i and final inspection meets specification.Lot release to bp58 on 01-feb-2017.(b)(4)- raw material lot bp-80 lot - 7735108 received from supplier (b)(4).Ati (b)(4) certificate of test for titanium meets specification.Raw material received/putaway checklist meets the requirements.Inspection sheet for in-process/inspect dimensional/final met inspection acceptance criteria.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.Scn no: (b)(4), ethicon ((b)(4)), ¿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

(b)(6) reported the following: it was reported that during an open reduction internal fixation of the right hip using a trochanteric fixation nail (tfn) on (b)(6) 2017, it was identified that no built-in locking mechanism was present in the cannulation of the tfn.The surgeon implanted the complained device into the patient, and then immediately after, implanted a helical blade.Then the surgeon attempted to lock the helical blade in place according to proper surgical technique by inserting the flexible screwdriver down the cannulation of the proximal end of the tfn, and attempted to locate the built-in locking mechanism, in order to engage the screwdriver and lock the helical blade in place.The surgeon was unsuccessful in locating the locking mechanism.After using fluoroscopy to check for the location of the locking mechanism, it was determined that there was no locking mechanism present inside the cannulation of the tfn.At this point the surgeon had no choice but to remove the complained implant (tfn) from the patient, and also removed the helical blade.Upon thorough inspection of the complained implant, it was determined that the locking mechanism which is supposed to be built into the cannulation of the complained device was not there, and never was there.Fluoroscopy was then used to determine that the locking mechanism had not fallen out in the patient, and this was confirmed - the locking mechanism was not in the patient.To be clear, it was confirmed with complete certainty that the locking mechanism was not present inside the cannulation of the complained implant, where it should be according to manufacturing specifications.In order to continue the surgery, the surgeon then reamed the intramedullary canal one millimeter wider, and then implanted a new, slightly larger tfn of the same length as the complained implant.The surgeon then implanted the helical blade, and successfully engaged the locking mechanism which was present in the newly opened implant.The surgeon finished the surgery successfully.The delay in surgery was approximately forty-five (45) minutes, due to the absence of the locking mechanism in the complained implant.It should also be noted that when the original complained implant was opened out of its sterile packaging, the small clear plastic round cap which is always found in the proximal opening of the nail when the nail is opened out of the package was not present.This complaint is for one device concomitant medical devices helical blade (part#unknown, lot # unknown) screwdriver (part#unknown, lot # unknown) and small plastic cap (part#unknown, lot # unknown).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was 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.

Manufacturer Narrative

Additional narrative: product development investigation was completed.This complaint is confirmed for the locking mechanism is missing from the tfn nail as complaint suggests.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition.Appropriate actions have been taken to address the matter.(b)(4).Device was 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 TROCH FIXATION NAIL 380MM/RIGHT-STER
• 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: 6681542
• MDR Text Key: 78903483
• Report Number: 1719045-2017-10620
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.418S
• Device Lot Number: H302839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 07/11/2017; 07/28/2017
• Supplement Dates FDA Received: 07/14/2017; 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention