MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE

Device Problem Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of event: park, s; yang, k; yoo, j, yoon, h and park, h.(2008).The treatment of reverse obliquity intertrochanteric fractures with the intramedullary hip nail.J trauma, 65, 852¿ 857.This report is for unknown (pfn) system /unknown quantity/unknown lot.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.Udi: unknown part number, udi is unavailable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following literature article park, s; yang, k; yoo, j, yoon, h and park, h.(2008).The treatment of reverse obliquity intertrochanteric fractures with the intramedullary hip nail.J trauma, 65, 852¿ 857.This study represents the retrospectively reviewed of the clinical results of 46 cases of reverse obliquity or transverse intertrochanteric fracture treated with intramedullary hip nails.The mean age of the 19 men and 27 women was 63 years (range: 22¿93 years).Twenty-five fractures were fixed with proximal femoral nail (pfn) (synthes, (b)(4)and), and 21 fractures were fixed with intertrochanteric subtrochanteric nail (zimmer, (b)(4)).Among 40 patients, followed up for more than 6 months, 22 31-a3.3 fractures (84.6%) out of 26 and all 14 a3.1 or a3.2 fractures were healed after the first operation.The mean union time was longer in the a3.3 group (5.98 months, range 3¿17 months) compared with that in the a3.1 or a3.2 group (4.65 months, range 3¿9 months).The lesser trochanteric fragment and posteromedial defect in 31- a3.3 fracture seems to play an important role in the stability after intramedullary hip nailing.The causes of fixation failure in the pfn group were associated with excessive sliding of femoral neck screw, which was aggravated by toggling motion in the 31-a3.3 fractures.This is report 1 of 7 for (b)(4).This report is for an unknown (pfn) system and refers to four cases of fixation failure which were discovered post-operatively.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5823191
• MDR Text Key: 50507069
• Report Number: 2520274-2016-13664
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention