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U.S. Department of Health and Human Services

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

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SYNTHES MONUMENT 10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
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.
 
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Brand Name10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER
Type of DeviceROD,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 Key6147204
MDR Text Key61506274
Report Number1719045-2016-10880
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number456.358S
Device Lot Number7749759
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/06/2016 Patient Sequence Number: 1
Treatment
ONE (1) UNKNOWN 5.0MM LOCKING SCREW; PART# 456.303S, LOT# 9961328, QUANTITY: 1
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