MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 456.358S

Device Problem Break (1069)

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of initial implant procedure is unknown.Therapy date of concomitant devices is unknown.(b)(4).Device history records review was completed for part# 456.358s, lot# 7749759.Manufacturing location: (b)(4), manufacturing date: jul 30, 2014, expiry date: jun 30, 2023.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.The device was received and the product evaluation is in progress.No conclusion can be drawn.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.

Event Description

It was reported that on (b)(6) 2016, patient underwent a hardware removal and revision surgery due to a nonunion and device breakage.Patient was initially implanted with one (1) 10mm/130 degrees titanium cannulated trochanteric fixation nail, two (2) 5.0mm locking screws, and one (1) 11.0mm titanium helical blade approximately five (5) months ago for a right femur fracture.Exact date of initial surgery is unknown.No reported issue during initial surgery.Postoperatively, surgeon continued to follow up with the patient on unknown dates and suspected a nonunion on unknown date.On two separate occasions (dates unknown), surgeon advised the patient to remove the interlocking screw.However, patient refused.It is unknown what caused the surgeon to suspect a nonunion.It is unknown if patient experienced any adverse events.After suspecting a nonunion, x-rays taken on (b)(6) 2016 confirmed that the nail broke at an occupied distal interlocking screw hole.The screw in that hole was also broken.Surgeon believed that due to the nonunion of the fracture, the devices broke.Patient underwent hardware removal and revision surgery on (b)(6) 2016.No fragments generated from the broken devices.All devices were easily removed without medical intervention.Patient was revised to a larger nail, a new helical blade, and a new screw.Surgery was successfully completed without surgical delay.Patient status/outcome was reported as stable.The locking screws were discarded.The nail and helical blade will be returned for manufacturing evaluation.Concomitant devices reported: 5.0mm locking screw (part# unknown, lot# unknown, quantity: 1); 11.0mm titanium helical blade 90mm sterile (part# 456.303s, lot# 9961328, quantity: 1).This report is for one (1) titanium cannulated trochanteric fixation nail.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device: one 10mm/130 deg ti cann troch fixation nail 380mm/right-ster (part number: 456.358s, lot number: 7749759, mfg date: 30jul2014).The complaint condition is confirmed.A visual inspection and drawing review were performed as part of this investigation.The returned part was determined to be suitable for their intended use when employed and maintained as recommended.The returned implant is part of depuy synthes (titanium trochanteric fixation nail system.The nail is designed for intramedually fixation of proximal femur fractures (per technique guide).Upon visual inspection of the device it can be seen that the distal tip (49.80 mm in length) has broken off from the device, the balance of the device shows signs of being implanted/removed.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the weld is already broken.A review of the current design drawing / manufactured revision for the top level assembly was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.All measurements were done using calipers.No definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.One helical blade (part number: 456.303, lot number: 9961328) was also returned and no complaint allegations were made against this implant therefore no further investigation is required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 10MM/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: 6147204
• MDR Text Key: 61506274
• Report Number: 1719045-2016-10880
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 456.358S
• Device Lot Number: 7749759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE (1) UNKNOWN 5.0MM LOCKING SCREW; PART# 456.303S, LOT# 9961328, QUANTITY: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 136