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

Device Problem Fracture (1260)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is being filed after the subsequent review of the following journal article: kang.R., stern.P.(2002).Humeral nonunion associated with metallosis secondary to use of a titanium flexible humeral intramedullary nail.The journal of bone & joint surgery.Volume 84 - a, pages 2266 - 2269.Usa.This report is for an unknown titanium flexible humeral nail / unknown quantity / unknown lot.Udi: unknown part number, udi is unavailable.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.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 journal article: kang.R., stern.P.(2002).Humeral nonunion associated with metallosis secondary to use of a titanium flexible humeral intramedullary nail.The journal of bone & joint surgery.Volume 84 - a, pages 2266 - 2269.Usa.A (b)(6) right-hand-dominant woman had fracture in (b)(6) 1999 after a fall in the bathtub.The fracture was treated with closed reduction, reaming, and intramedullary nailing with a titanium flexible humeral nail (synthes, (b)(4)).Radiographs demonstrated a delayed union of the humeral fracture.In (b)(6) 2001, eighteen months after the injury, the humeral nail was removed because of progressive pain and nonunion.Examination of the nail showed extensive loss of the anodization at the level of the nonunion and wear of several consecutive segmental articulations at the same level, with a crack extending into one of the segments.After the nonunion was taken down, transverse osteotomies were performed at the fracture ends after which plate osteosynthesis was performed with use of a 4.5-mm stainless-steel low-contact dynamic compression plate and iliac crest bone grafting.Radiographic union was noted twelve weeks postoperatively.This is report 1 of 1 for (b)(4).This report is for unknown titanium flexible humeral nail.

• 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: 5894437
• MDR Text Key: 52719606
• Report Number: 2520274-2016-14289
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2016
• Initial Date FDA Received: 08/22/2016
• 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
• Patient Age: 54 YR